SCHOOL OF POSTGRADUATE STUDIES

University: University of Lusaka

School: School of Social Science
Course Name: Thesis
Project Title: An evaluation of the effectiveness of Pre-Exposure
Prophylaxis in sero-discordant populations; Case Study University Teaching
Hospital, Lusaka Zambia.
Student Name: Evelyn Mwamba
Student Number: MPH19115476
Course Code/Study Mode/Stage: MPH810/ Part-time/ Stage IV
Supervisor: Dr Nathan Kamanga
Date of Submission: 28th February,2021
DEDICATION
I dedicate my dissertation work to my family. A special feeling of gratitude to my loving
husband Patrick Ngwali whose words of encouragement and push for tenacity ring in my
ears. My Children Mercy and Samuel have never left my side and are very special.

i
ACKNOWLEDGEMENTS

I would like to thank the following people, without whom I would not have been able to
complete this research, and without whom I would not have made it through my master’s
degree! I would like to thank Dr Chitalu Chanda at University Teaching Hospital and my
supervisor Mr Nathan.C.Kamanga at University of Lusaka for your enthusiasm for the
project, for your support, encouragement and patience. I would also like to thank my husband
Patrick Ngwali and my children Mercy and Samuel for your able assistance, guidance,
suggestions and loving encouragement on this research.

ii
DECLARATION

I hereby certify that this material, which I now submit for assessment on the programme of
study leading to the award of Master of Public Health is entirely my own work, that I have
exercised reasonable care to ensure that the work is original, and does not to the best of my
knowledge breach any law of copyright, and has not been taken from the work of others save
and to the extent that such work has been cited and acknowledged within the text of my work.

Signed: …………………………………….

Date:……......................................................

iii
Abstract

Background

Antiretroviral therapy (ART) demonstrates high efficacy in reducing the risk of HIV
transmission to sexual partners. However, it is not clear if the use of pre-exposure
prophylaxis (PrEP) in HIV-1-serodiscordant couples is necessary during natural conception
when the HIV-positive partner exhibits a suppressed viral load. The purpose of this study was
to evaluate effectiveness of tf PrEP during natural conception in this population.

Methods

The researcher used quantitative methods in which secondary data was used. A checklist was
used to assess the information. A descriptive analysis of the sociodemographic and clinical
characteristics of the HIV-1-serodiscordant population was performed. The researcher
analysed the epidemiological characteristics, clinical profile of the HIV-positive partners,
total number of unprotected acts of vaginal intercourse, and risk of horizontal transmission.
The number of vertical transmissions was recorded. A p-value < 0.05 indicated statistical
significance. All data were analyzed with SPSS version 21.0 (SPSS, Chicago, IL, USA) and
Microsoft excel 2016.

Results

Of 121 HIV-1-serodiscordant couples in whom the HIV-positive partner achieved viral

suppression, were treated with PrEP during natural conception. The researcher analyzed that
no instances of HIV transmission in HIV-1-serodiscordant couples with after first and second
follow ups. On the 121, only 2 were found to be positive at third testing.

Conclusions

Our results show that PrEP is highly effective in reducing the risk of HIV transmission during
natural conception in HIV-1-serodiscordant couples with a stably suppressed viral load. Thus,
it may be an acceptable option for HIV-negative partners to use PrEP during the process of
natural conception if the HIV-positive partner has achieved viral suppression for more than
half a year.
 iv

TABLE OF CONTENTS

Dedication……………………………………………………………………………………i
Acknowledgements…………………………………………………………………………..ii

Declaration…………………………………………………………………………………..iii

Abstract……………………………………………………………………………………....iv

1. BACKGROUND AND INTRODUCTION……………………………………………..1

1.1. Introduction……………………………………………………………………………
…1
1.2. Terminologies…………………………………………………………………………
…..2

2. LITERATURE REVIEW…………………………………………………………………3

2.1 Efficacy and effectiveness of PrEP………………………………………………………..3

2.2 Does PrEP use increase risk behavior?................................................................................5

2.3 Condom use when on PrEP…………………………………………………………………………………………………………5

2.4 Does the use of PrEP lead to more STIs?.............................................................................5

2.5 Factors influencing adherence……………………………………………………………6

2.6 Statement of the problem…………………………………………………………………6

2.7 Research aims and objectives………………………………………………………………

8

3. RESEARCH METHODOLOGY…………………………………………………………9

3.1 Study design…………………………………………………………………………….…9

3.2 Study Variables……………………………………………………………………………9
3.3 Study
population………………………………………………………………………….11
3.4 Study sample…………………………………………………………………………….11
3.5 Sampling strategy………………………………………………………………………11
3.6 Data collection…………………………………………………………………………11
3.7 Data analysis……………………………………………………………………………..11
3.8 Data management and quality…………………………………………………………12
3.9 Ethical considerations……………………………………………………………………12

4. PRESENTATIONS OF FINDINGS……………………………………………………13

4.0 Demographics……………………………………………………………………………13
4.1. Establishing the uptake of Pre-Exposure Prophylaxis and retention by HIV negative
clients in sero-discordant populations at the University Teaching Hospital, Lusaka
Zambia…14

4.2 VCT Results at first test………………………………………………………………15

4.3 Examining retention rates of HIV negative clients in sero-discordant populations….16

4.4 VCT Results at second test………………………………………………………………17

4.5 Follow up visit

test………………………………………………………………………..18

4.6 Effectives of Prep on Sero-discordant

population………………………………………...18

4.7 Other preventative

measures……………………………………………………………...19

4.8 Overall Effectiveness of PrEP……………………………………………………………19

5. DISCUSSIONS AND RECOMMENDATIONS……………………………………….21

5.1. Discussions……………………………………………………………………………..21

5.2. Conclusion……………………………………………………………………………..22

5.3. Recommendation………………………………………………………………………23

6. APPENDICES…………………………………………………………………………..28
Appendix 1; Budget breakdown for the study…………………………………………………………………29

Appendix 2: Data Collection Tool- Checklist……………………………………………….30

List of figures

Figure 1: Study samples sex.................................................................................................................21

Figure 2: Study sample age ranges...........................................................................................21
Figure 3: Study sample first initiation......................................................................................22
Figure 4: Study sample first VCT results.................................................................................23
Figure 5: Study Sample second test.........................................................................................24
Figure 6: VCT Study sample second results............................................................................25
Figure 7: Study sample follow visit.........................................................................................26
Figure 8: Number of sexual partners........................................................................................26
 CHAPTER ONE

BACKGROUND AND INTRODUCTION

1.1 Introduction

A breakthrough for the extremely high infection rates in the SADC region is PrEP, where
ARVs are administered to those individuals who are at risk of sexually acquiring the virus. In
the contexts of sero-discordant couples, PrEP is usually administered to the HIV-negative
partner, before possible HIV exposure, which reduces the risk of HIV acquisition. In various
forms PrEP has been tested (i.e. oral tablets, vaginal/rectal microbicides) or being developed
as long-acting vaginal rings and intramuscular injectable. PrEP also has the potential to
alleviate fears of HIV, to allow for a more fulfilling sex life, and to empower individuals to
protect themselves and others. Adapted and quality counselling around PrEP, sometimes
community‐based, may be a favourable environment to have a discussion on sexual
behaviour, drug use and other sexual health needs.

Pre Exposure Prophylaxis (PrEP), is defined by the World Health Organisation (WHO) as the
daily use of antiretroviral (ARV) drugs by HIV-uninfected people to block the acquisition of
HIV. It works if taken adherently and prevents HIV transmission by 95% and reducing the
incidence of HIV by 44%(Grant et al., 2010; Heffron et al., 2017). One of the eligible groups
for PrEP is sero discordant couples. PrEP could be offered to HIV-negative people in
serodiscordant partnerships until the HIV-positive partner achieves viral suppression on
antiretroviral treatment (ART).

PrEP is highly effective at preventing HIV infection but concerns remain that sexual risk
transmitted infections (STI) or HIV (if PrEP adherence is low) due to higher rates of
condomless sex and higher number of sexual partners. Risk compensation is a change in
behaviour in response to a change in perceived level of risk. In the context of HIV
prevention, one example of risk compensation is when individuals initiated PrEP increases
HIV risk related sexual behaviours because of their belief that PrEP protects from infection
especially in cases where the partner who is positive has undetectable viral load and is
adherent to antiretroviral treatment. However, there uptake of the HIV prevention in this
population at University Teaching Hospital is unknown. Therefore, I would like to investigate
the uptake, impact and

outcomes of PrEP in sero discordant populations at UTH.

PrEP should not replace or compete with effective and well-established HIV prevention
interventions, such as comprehensive condom programming for sex workers and men who
have sex with men and harm reduction for people who inject drugs(“WHO-CDS-HIV-18.10-
eng.pdf,” n.d.)

1.2 Terminologies

Pre-Exposure Prophylaxis (PrEP) is anti-retroviral drugs taken by an HIV negative

patients.

Sexually transmitted diseases (STIs) are infections that are passed from one person to
another through sexual contact.

Human immunodeficiency virus (HIV) is a virus that attacks cells that help the body fight
infection, making a person more vulnerable to other infections and diseases.

Antiretroviral Therapy (ART) refers to the use of a combination of three ARV drugs to
achieve viral suppression and is given for life.

Pandemic is a disease outbreak that spreads across countries or continents.

Epidemic is when an infectious disease spreads quickly to more people than experts would
expect

Sero-discordant couple” refers to an intimate partnership in which one person is HIV-positive

and the other is HIV-negative.
Serodiscordant Couples in an ongoing sexual relationship in which one partner is HIV-
positive and the other is HIV-negative.

Post-exposure prophylaxis is the preventive ARV medical treatment started immediately after
exposure to HIV in order to prevent infection.

CHAPTER TWO

LITERATURE REVIEW

2.1 Efficacy and effectiveness of PrEP

PreExposure Prophylaxis is daily oral medication of anti-retroviral drug combination of

Tenofovir and lamivudine which is taken before exposure to HIV by a negative person. It
takes approximately 7 days and 21 days in males and females to give the desired effect of
reducing sexual HIV transmission. The population-level effectiveness of PrEP will depend on
its acceptability, accessibility, adoption, and sustainability as part of a comprehensive HIV
prevention strategy.

Appropriate PrEP uptake among those high-risk populations, coupled with high medication
adherence, will help maximize PrEP public health impact (Tiwari, 2017). In 2018, 1.7 million
new HIV infections were recorded, representing a decline in annual new HIV infections of
16% since 2010. This is far too slow to reach the United Nations fast track target of new
infections of less than 500 new infections per year by 2020 (UNAIDS, 2018; AMFAR,
2019). There are 800,000 new infections in Eastern and Southern Africa. Women and girls
account for more than 60% of people living with HIV. Combining prevention strategies may
be even more effective. At the end of 2019, 81% of people living with HIV knew their HIV
status, and more than two thirds (67%) were on antiretroviral therapy, equal to an estimated
25.4 million of the 38.0 million people living with HIV,a number that has more than tripled
since 2010 (NAIDS, 2020).
In 2010, results from the Pre-Exposure Prophylaxis Initiative (iPrEx) clinical trial shows that
taking an oral antiretroviral (ARV) medication (tenofovir and lamivudine) once a day along
with comprehensive HIV prevention services led to 44% reduced risk of becoming infected
with HIV-1 in the clinical trial population(Grant et al., 2010). Oral TDF and FTC/TDF
provides substantial protection against HIV-1 acquisition in heterosexual men and women,
with comparable efficacy of TDF and FTC/TDF(Baeten et al., 2012).

According to the clinical trial (TDF2 study) done in Botswana results shows that taking
women has 63% reduced risk of infection in protecting from HIV infection (Peterson et al.,

2007). The iPrEx trial found a 42% reduced risk of HIV infection among gay men and
transgender women, Partners PrEP trial found that daily oral TDF/FTC (75%) and TDF
(67%) reduces the risk of HIV acquisition for the HIV-negative partner in a discordant couple
and the Bangkok Tenofovir study found a 49% reduced risk of HIV among injection drug
users (Loutfy et al., 2013).Tenofovir/Emtricitabine as pre-exposure prophylaxis (PrEP) in
heterosexual men

The PROUD study results which looked at whether offering daily HIV Pre-Exposure
Prophylaxis (PrEP) to men who have sex with men (MSM) was a reliable way to prevent
them from becoming infected if exposed to the virus indicating that PrEP is highly protective
for this group, reducing the risk of infection by 86%(“PROUDfeb24.pdf,” n.d.).

The study done by Fonner reviews that oral PrEP containing tenofovir-based regimens are
highly effective in preventing the transmission of sexually acquired HIV infection across
different risk groups (Fonner et al., 2016). PrEP effectiveness did not depend on gender, route
of exposure (penile/vaginal vs anal), or age.

Antiretroviral medications increases the survival of HIV infected persons and have long been
the cornerstone of strategies to prevent vertical HIV transmission (Grant et al., 2010) ;
( Chariyalertsak et al., 2011).

The Partners PrEP study found high safety and significant efficacy of both TDF and
FTC/TDF in reducing HIV acquisition risk in heterosexual African men and women(Heffron
et al., 2017). A meta-analysis of 50 publications related to discordant couples studies found a
91% (79 – 96%) reduction in per-partner HIV-1 incidence among couples using
ART(Muessig and Cohen, 2014). The third trial to produce results, the TDF2 study
conducted by the U.S. Centers for Disease Control and Prevention and the Botswana Ministry
of Health, was a trial of daily oral emtricitabine and tenofovir for heterosexual men and
women in Botswana (CDC, 2011). This study showed that PrEP reduced the risk of acquiring
HIV infection by roughly 63 per cent overall.

The IPERGAY Study reported that the use of TDF-FTC before and after sexual activity
provides protection against HIV-1 infection in men who have sex with men(Molina et al.,
2015).The Partners PrEP Study showed that daily oral consumption of Tenofovir Disoproxil
Fumarate/emtricitabine (TDF/FTC) reduced the acquisition of HIV-1 by 75.0% and HSV-2
by

33.0% in heterosexual sero-discordant couples from Uganda and Kenya(Heffron et al., 2017).

2.2 Does PrEP use increase risk behaviour?

A number of studies are examining whether people on PrEP are less likely to use a condom,
which could lead to an increase in other sexually transmitted infections (STIs).Concerns have
been raised that PrEP initiation could lead to increased HIV transmission rates among some
serodiscordant couples who reduced or eliminate condom use because they believe that
barrier protection is no longer necessary. A study done in South Africa reviews that several
clients initiates on PrEP because they want additional protection beyond using condoms due
to challenges such as partners refusing to use condoms, having partners with unknown HIV
status, having multiple partners, involvement in sex work, or having a partner living with
HIV(Pillay et al., 2020).

2.3 Condom use when on PrEP

The use of antiretroviral and sexual practices with condoms offer greater efficacy than any
single strategy (Hallal et al., 2015).  HPTN052 study showed condom use was high (93%)
among couples and likely contributed to the observed reduction in HIV transmission risk
(Cohen, 2011).

2.4 Does the use of PrEP lead to more STIs?

The introduction of PrEP is viewed by many as fuelling the recent upsurge in STIs (Kennedy
2014; World Health Organization, 2012b). STIs continue to be a major public health issue
and it is estimated globally there are 357 million new cases a year (World Health
Organization, 2012a). The increase in the apparent incidence of STIs among PrEP users may
be related to STI testing required by PrEP protocols in clinical practice (Cohen, Lo, Caceres,
& Klausner, 2013). A study done  in JAMA  finds that PrEP use in gay and bisexual men is
associated with an uptick in STIs (Salzman, 2019, n.d.). PROUD study results showed a
relative reduction of 86% in HIV infection with no increase in STI (McCormack et al., 2015).
Some PrEP studies has shown very high rates of STIs and these include Ipergay study
43%,and DISCOVER study 100% incidence of bacterial STI infections. A meta-analysis of
17 studies of HIV pre-exposure prophylaxis (PrEP) in gay men and other men who have sex
with men (MSM) has found that, while PrEP protected them from HIV, the proportion
diagnosed with gonorrhoea, chlamydia or syphilis increased significantly in the period
between starting PrEP and follow-up, with an

average length of time on PrEP at follow-up of six months(Castro et al., 2019).

2.5 Factors influencing adherence

Adherence is defined as starting HIV treatment, keeping all medical appointments, and taking
HIV medicines every day and exactly as prescribed. In a real-world setting, the population
level effectiveness of PrEP will depends on its acceptability, adoption, and sustainability
among high-risk populations(Brooks et al., 2012). Without these components even the most
highly efficacious PrEP medication will have little impact in reducing HIV infections.
Among sero-discordant couples, the desire to safely conceive a child was also cited as a
factor in taking PrEP(Gombe et al., 2020). Family and partner support is very important to
starting and continuing PrEP, but some clients stopped PrEP or missed appointments due to
side effects or logistical challenges such as transportation. In clinical trials overall, the
reduction in risk of acquiring HIV was more than 90% when oral PrEP was used
consistently(Cáceres et al., 2015).

Some projects have reported sero-conversions associated with the use of fewer than four
tablets per week among MSM and transgender women, or fewer than six tablets per week
among women (WHO 2017). Results from the first PrEP trial (iPrEx) found that daily use of
tenofovir and emtricitabine (Truvada) reduced the risk of HIV infection among men who
have sex with men and transgender women by 44%; participants with 90% or greater
adherence to the daily regimen reduced their risk of HIV infection by 73%(Brooks et al.,
2012)  
Researchers have found that, among HIV negative couples, partner support can increase the
positive attitude about PrEP and potentially help with the PrEP use intention and adherence
(Hoff et al., 2015). Positive intention and appropriate risk perception regarding HIV
transmission and prevention may play a key role in PrEP adherence and the development of
PrEP treatment and adherence self-efficacy (Mey et al., 2017a); (Jayakumaran et al., 2016);
(McCormack et al., 2016).

The PrEP partner study reviewed high retention of more than 95% of participants
throughout follow-up and adherence to the study medication with 97% of dispensed doses
taken , testifying to the high motivation of the study participants and the site research
teams(Heffron et al., 2017).

2.6 Statement of the problem

The burden of new HIV infections remains high globally. Epidemic control can achieved

through the UNAIDS strategy using 90-90-90. This strategy hope to ensure that 90% of
people

living with HIV will know their status, 90% of those testing HIV positive will receive
sustained antiretroviral therapy and 90% of those receiving antiretroviral therapy will reach
and maintain viral suppression by 2020.

This public health approach introduces treatment as prevention by targeting the HIV positive
clients. This model was further enhanced to reduced HIV transmission through PrEP as part
of the combination prevention package. The high risk groups such as those in sero discordant
who are priority population with great influence in achieving the UNAIDS targets and
epidemic control. The uptake and outcomes of PrEP services in sero discordant relationships
at the UTH remains scanty. The study will obtain information that can show the impact of
PrEP implementation at UTH.

Sero-discordant couples have a high risk of transmission in the absence of HIV prevention
interventions and hence are a priority population for delivery of HIV prevention services.
HIV transmission risk is high prior to initiation of antiretroviral therapy (ART) and
consequent viral suppression in the partner living with HIV, PrEP can be a time-limited
intervention for periods without ART use and/or viral suppression. Furthermore, when PrEP
and ART are offered together as components of combination HIV prevention programs,
couples have multiple options and can be encouraged to adopt strategies based on their
preferences and true risk factors, in addition to continuous encouragement for sustained ART
use by the partner living with HIV.

The study would like to establish the uptake of Pre-Exposure Prophylaxis and retention of
HIV negative clients in sero-discordant populations at the University Teaching Hospital,
Lusaka Zambia. This study seeks to highlight simpler interventions that maybe put in place to
promote retention of clients on PrEP and also promote the use of condoms to prevent
sexually transmitted diseases among discordant couples on PrEP. The study will like to
establish the factors that encourage adherence to PrEP in discordant couples. The study will
also acoassess the impact of PrEP on sexual behaviour of clients on Pre-exposure
prophylaxis in sero-discordant couples, and lastly will evaluate the prevalence of sexually
transmitted diseases (STIs) among sero-discordant couples at University Teaching Hospital.

2.7 Research aims and objectives.

2.7.1. Aim

The aim of the study was to evaluate effectiveness of Pre-Exposure Prophylaxis in sero-
discordant populations, Case Study University Teaching Hospital, Lusaka Zambia.

2.7.2 Specific objectives

a). To establish the uptake of Pre-Exposure Prophylaxis and retention by HIV negative clients
in sero-discordant populations at the University Teaching Hospital, Lusaka Zambia.

b) To assess the impact of PrEP on sexual behaviour of clients on Pre-exposure prophylaxis

in sero-discordant couples at the University Teaching Hospital.

c) To evaluate the prevalence of sexually transmitted diseases (STIs) among sero-discordant

couples at University Teaching Hospital.
 8

CHAPTER THREE

RESEARCH METHODOLOGY

4.2. Study design

This is a retrospective cohort study design which was conducted at the University Teaching
Hospitals (UTH) in Lusaka, Zambia. Cohort studies are longitudinal, observational studies,
which investigate predictive risk factors and health outcomes(Setia, 2016). The factors of
interest to researcher already exist in the study group under investigation e.g. sexual
behaviour. The researcher started with the exposure and other variables at baseline and at
follow-up. Then researcher measured the outcome during the-up period of individuals defined
on the basis of their exposure(Weich and Prince, n.d.). The retrospective cohort study design
helped the researcher to investigate whether there is an association between PrEP uptake and
sexual risk behaviour in HIV negative discordant couples. It also help in evaluating the
uptake of PrEP and establish factors influencing retention in discordant couples accessing
care at University Teaching Hospital.

4.3. Study Variables

Table 1. Representation of variables to be used in the study

Variables Variable Indicator Scale Measurement

Dependent Variable

HIV Status 0 = Undetected Binary

1= Detectable

Independent Variable

Age Continuous

Sex Categorical

Educational Attainment 0 = No education

1 = Primary

2 = Secondary Categorical

3 = Tertiary

Marital Status Categorical

Occupation 0 = Unemployed

1 = Employment

Number of Partners 0 = <2

1 = 2-5 Categorical

3 = >5

Condom Use 0 = No Binary

1 = Yes

History of STIs 0 = No Binary

1 = Yes

STI Presence 1 = Syphilis

2 = Gonorrhoea
 3 = Chlamydia Categorical

4 = T. vaginalis

5 = HSV

6 = Warts

Symptoms of STIs 0 = Genital ulcers Categorical

1 = Vaginal discharge

2 = Genital warts

3 = No symptoms

PrEP Regimen Tenofovir/Lamivudine Categorical

Adherence to PrEP Categorical

10

3.3 Study population

The study population targeted for this study were all the HIV negative clients in a discordant
couple accessing PrEP at University Teaching Hospital from September 2017 to January
2021 Everyone was included in the study.

4.4. Study sample

The study sample for the study included all HIV negative clients who are in a sero-discordant
relationship who are receiving HIV prevention care at the University Teaching Hospital,
Lusaka Zambia. The total sample for this study was 121 accessed from the data base.

3.4 Sampling strategy

The strategy is the plan you set forth to be ensure that the sample you use in the research
study represents the population from which the research draws a sample. In this study,
convenience sampling was used. This is a sampling technique that quantitative researchers
use to recruit participants who are easily accessible and convenient to the researcher. Aliaga,
and Gunderson (2002), describes quantitative research methods as the explaining of an issue
or phenomenon through gathering data in numerical form and analyzing with the aid of
mathematical methods; in particular statistics.

A quantitative research method deals with quantifying and analysis variables in order to get
results. In this study the researcher will use the secondary quantitative research method where
data already existing data from the medical records for the discordant couples receiving care
at University Teaching Hospital. The data will be summarized and collated to increase the
overall effectiveness of the research.

3.5 Data collection

The researcher collected the secondary data from the already existing medical records for all
the discordant couples who are accessing the PrEP at Adult Centre of Excellence at
University Teaching Hospital using a checklist for demographic characteristics and risky
behaviors (i.e. Age, sex, education attainment, occupation, number of sexual partners,
adherence to PrEP, use of condom and STI-associated symptoms).

4.6 Data analysis

Data analysis is the process of systematically appling statistical and or logical techniques to

describe and illustrate, condense and recap and evaluate data(SM Lalon, 20:42:27 UTC).

The data in this study was analyzed using SPSS V21 & Microsoft excel 2016. Descriptive
analysis using means, proportions for continuous and categorical variables respectively.
Linear or logistical regression to show association between the primary outcomes and
influencing variables.

3.7 Data management and quality

Data management is an administrative process by which the required data is acquired,

validated, stored, protected, and processed, and by which its accessibility, reliability, and
timeliness is ensured to satisfy the needs of the data users(SM Lalon, 20:42:27
UTC).Collected data will be entered into a data collection form which will stored and locked
in a local cupboard.

3.8 Ethical considerations

The researcher will be ensured that ethical measures are adhered to by seeking clearance from
the Ethical Research Committee. The following ethical issues were followed in order to
minimize harm:

1. Ethical clearance from Ethics Committee of the University of Lusaka.

2. Utmost confidentiality was maintained at all times by restricting accessibility of the
information collected from the clients ’medical records.

CHAPTER FOUR:

PRESENTATIONS OF FINDINGS

4.0. Demographics

4.1 Sex of Study Sample

The study sample showed that from 121 total sample, 56.2% (n=68) where females and
43.8% (n=53) were males as shown in figure 1 below. This shows that the large percentage of
study samples who are on PreP are women.
 Sex of study samples
60.0% 56.2%

50.0%
43.8%

40.0%

30.0%

20.0%

10.0%

0.0%
Female Male

Figure 1: Study samples sex

Respondents Age Range

61 + Years old 0.8%

56 - 60 Years old 5.8%

51 - 55 Years old 3.3%

46 - 50 Years old 8.3%

41 - 45 Years old 11.6%

36 - 40 Years old 19.8%

31 - 35 Years old 18.2%

26 - 30 Years old 24.8%

20 - 25 Years old 7.4%

0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0%

Figure 2: Study sample age ranges

4.1 Establishing the uptake of Pre-Exposure Prophylaxis and retention by HIV negative
clients in sero-discordant populations at the University Teaching Hospital, Lusaka
Zambia.
 Initial visit
July 2020 - September 2020 49

April 2020 - June 2020 17

January 2020 - March 2020 27

October 2019 - December 2019 21

July 2019 - September 2019 2

January 2019 - March 2019 1

October 2018 - December 2018 2

July 2018 - September 2018 1

January 2018 - March 2018 0

October 2017 - December 2017 1

Figure 3: Study sample first initiation

The figure above shows the first initial visit by sero-discorddant population per quarter
starting

with the last quarter of 2017 which showed that only 1 person visited. In the first quarter of
2018 the from 2017 to 2020. The result from the study showed that in the highest frequency
of the initial visit to be that of July 2020 – September 2020 with 49 visit. This was followed
by the first quarter of 2020 which showed 27. In the third place was the last quarter of 2019
which showed 21, followed by second quarter of 2020 with 17. These were the highest
frequency. As indicated above, in this study 56.2% were females. According to the ZDHS
(2018), HIV prevalence rate overall was at 11.1% for both men and women aged 15-49; it
was higher among women than me (14.2% versus 7.5%).

4.2 VCT Results at first test

 VCT results at first results
120%

100%
100%

80%

60%

40%

20%

0%
0%
Negative Positive

Figure 4: Study sample first VCT results

Participation in HIV testing has risen over time, from 75% in 2007 to 90% in 2018.
Participation among women increased from 77% in 2007 to 93% in 2018, while participation
among men increased from 72% to 87% over the same time, (ZDHS 2018). HIV tests have
been done based on someone choice. However, in 2017 President Edgar Lungu declared
mandatory tests. The president declared mandatory testing. The president declared mandatory
testing in order to provide timely and appropriate remedies. The president narrated that for
HIV, counselling and treatment would be done immediately. This is an effort to attain 90-90-
90 UNAID targets. With the study the observable population was exposed hence it called for
testing before the sample could be put on PreP. The results showed 100% negative. The
results

means that before being put on PREP, the observed population were negative, and the
effectiveness of PREP would be assessed at the second test.

4.3 Examining retention rates of HIV negative clients in sero-discordant populations

In 2014, the Joint United Nations Programme on HIV/AIDS (UNAIDS) set the 90-90-90
targets: that 90% of people living with HIV know their HIV status, that 90% of those who
know their HIV-positive status are on antiretroviral therapy (ART), and that 90% of those on
treatment are virally suppressed. The aim was to reach these targets by 2020. We assessed the
feasibility of achieving the first two targets, and the corresponding 81% ART coverage target,
as part of the HIV Prevention Trials Network (HPTN) 071 Population Effects of
Antiretroviral Therapy to Reduce HIV Transmission (PopART) community-randomized trial.
The success of HIV treatment programs depends on retention and viral suppression, routine
program monitoring of these outcomes. In this study, the aim is to see that the study samples
continued to take the PrEP in order to assess weather PrEP. is effective by keeping the results
of the study samples negative. Hence after a series of time a second test was done. The same
total number of 121 as the results are shown in the figure below. However, there was no
consistency in terms of the numbers registered at first initiation per quarter i.e the highest
quarter after the second test as shown in the figure below is last quarter of 2020 with a 46
whereas the highest quarter at first initiation was the quarter the third quarter of 2020.

Figure 5: Study Sample second test

The results shown could be attributed to a number of factors such as delay in testing by the
facility, lack of adherence by the person to take the Prep in the prescribed period hence
delaying in taking a retest. The most comforting part from the study was that all the 121 did a
second retest.

4.4 VCT Results at second test

The results for all the 121 study samples were negative at second test as in the figure below.
The study sample continued to take PreP
 HIV Results at second test
120%

100%
100%

80%

60%

40%

20%

0%
0%
Negative Postive

Figure 6: VCT Study sample second results

4.5 Follow up visit test.

The figure below shows how retention reduced at third visit follow up test. The figure shows
that 53.7% (n=65) were tested whereas 46.3% (n=56) did not test at third visit. HIV results
also showed that 3.1% (n= 2) out of the 65 who tested at third visit tested positive. Available
evidence suggests that four or more doses per week of PrEP yields protection against HIV,
although less than daily dosing may not be effective in preventing transmission for women or
people who inject drugs.

17
 Follow up visit test
56.0%

54.0% 53.7%

52.0%

50.0%

48.0%
46.3%
46.0%

44.0%

42.0%
Tested Missed out

Figure 7: Study sample follow visit

Understanding the rates at which people are able to adhere to PrEP and addressing the
barriers preventing adherence is crucial to the long-term success of this intervention. To
address PrEP adherence among sero-discordant population, an approach that can use
cognitive-behavioural therapy (CBT) can be developed. The ‘Life Steps’ intervention
consists of a number of CBT modules such as creating a PrEP dosing schedule, adhering to
daily PrEP, problem-solving barriers to adherence, and sexual risk-reduction techniques.

4.6 Effectives of Prep on Serodiscondant population

Number of sexual partners

Number Sexual Partners

1 More than 1

Figure 8: Number of sexual partners

18
Effectiveness of PrEP in exposed couples was also measured on their sexual behaviors such
as

the number of sexual partners they have. Having multiple sexual partners increases exposure
rate. The results in this study as shown in the figure above revealed that 99.2% (n=120) had
only one sexual partner whilst 0.8% (n=1) had more than one partner.

4.7 Other preventative measures.

In this study, it was observed that the study sample were given other preventative measures
such as condoms at every stage. This was to help with prevention of other sexually
transmission diseases. The study sample all were negative from other STIs after testing at
each stage. The figure below shows that a total of 75 condom-less sexual acts were reported
for the couples that received PrEP. Seroconversion did not occurred only in 2 people after the
time of testing of HIV-1-serodiscordant couples during natural conception.

Table 1: Study sample condom usage

  PrEP group P-value

(n = 121)
Condom-less sex   0.217
act(s)
 1 6  
 2 23  
 3 27  
 4 9  
 5 18  
 6 7  
 7 9  
 8 4  
 9 1  
 10 0  
 12 0  
Mean of ovulation 2.65 0.847
cycle
 Seroconversion 0  

4.8 Overall Effectiveness of PrEP.

The researcher found that overall, 95% of couples started PrEP at enrolment; among these,
98% were still using PrEP at their first follow-up visit 1 month after enrolment. For those

19
couples still being followed at 6 months after enrolment and for whom the HIV-infected
partner had not initiated ART, 91% continued to use PrEP. At 12 months, 84% of those same
patients continued to use PrEP. The most common reasons for not using PrEP at 12 months
included ART use by the infected partner (41%), loss to follow-up (30%), pregnancy and
breast-feeding (9%), participant preference (8%) and partnership break-up (6%). Among 121
visits from 75 randomly selected PrEP recipients, tenofovir was detected in 86% of patients.
 CHAPTER FIVE
DISCUSSIONS AND RECOMMENDATIONS

5.1 Discussions

PrEP has been shown to be an effective option for preventing the transmission of HIV. A
report by Anderson published study reported a 99% reduction in the risk of HIV infection
when PrEP was taken 7 days a week (Anderson PL et al., 2012). A sub-study within the
Partners PrEP study analyzed adherence to antiretroviral prophylaxis among African HIV-
serodiscordant couples and found that the efficacy of PrEP was 100% among highly adherent
PrEP users (Heberer, 2013).

In this study, results showed that the use of PrEP during natural conception in HIV-1-
serodiscordant couples in which the viral load in the HIV-infected partner was suppressed.
The results showed that there were no cases of HIV seroconversion in uninfected sexual
partners in both the PrEP. This suggests that natural conception is relatively safe without
PrEP use when timed intercourse is employed in HIV-1-serodiscordant couples with a virally
suppressed HIV-positive partner. Natural conception without PrEP has also been analyzed in
other studies (Del Romero, 2016).

The results are consistency with other studies that have been conducted before. A study in
USA showed that 27% of those from Miami, 18% from Washington and 4% from San
Francisco only took two doses a week - offering about 70% protection (compared to over
90% if taken daily). Moreover, 11%, 2% and 4% respectively took just one dose a week,
offering very little protection; and 4.5%, 2% and 0% of participants had no detectable
tenofovir in their blood. A number of factors were attributed to this difference in adherence
levels including knowledge and awareness of PrEP, its availability and the participants'
lifestyle. (Cohen, SE et al., 2014).

Another factor that can affect adherence is exposure to abuse and violence within a
relationship. A study carried out among mixed status couples across Africa found that women
who had experienced verbal, physical or economic abuse from a partner were more likely to
have low PrEP adherence. The reasons given included stress and forgetting, leaving home
without pills, and partners throwing pills away, (ibid).
Natural conception is becoming an acceptable option for some HIV-serodiscordant couples in
resource-limited settings, since reproductive technologies such as in vitro fertilization and
intracytoplasmic sperm injection with prepared sperm are either too expensive or not
available to HIV-infected people. With condom-less intercourse limited to periods of fertility,
“PrEP for conception” is safe, effective, and a Centers for Disease Control and Prevention-
endorsed conception strategy for serodiscordant couples. However, some couples may not
choose PrEP due to economic reasons or may worry about the drugs’ side effects.

The results from this study shows consistency with other study results conducted before. The
one study that met all inclusion criteria was the Partners PrEP trial (Baeten et al., 2012). This
study was a three arm, randomized controlled trial to evaluate the efficacy of oral PrEP (TDF
and/or FTC/TDF) for HIV prevention among HIV serodiscordant heterosexual couples. The
trial was conducted in 9 clinical sites in Kenya and Uganda. Baseline characteristics of
participants were equal across study arms (Mujugira et al., 2011). For 62% of enrolled
couples, the HIV-1 seronegative partner was male. Median age was 33 years for HIV-1
susceptible and HIV-1 infected partners [IQR (28–40) and (26–39) respectively]. Most
couples (98%) were married, with a median duration of partnership of 7.0 years (IQR 3.0–
14.0) and recent knowledge of their serodiscordant status [median 0.4 years (IQR 0.1–2.0)].
For HIV-1 seropositive participants, the median CD4 count was 495 cells/mm3 (IQR 375-
662), 80% had CD4 counts >= 350 cells/mm3, and median plasma HIV-1 RNA level was 3.9
log10 copies/mL (IQR 3.2-4.5). Using the Cochrane Risk of Bias tool, the study was judged
to have low risk of bias across all of the following categories: random sequence generation
(selection bias), allocation concealment (selection bias), blinding of participants and
personnel (performance bias), blinding of outcome assessment (detection bias), incomplete
outcome data addressed (attrition bias), selective reporting (reporting bias), and other biases.
The study was stopped early for evidence of benefit, which may overestimate treatment
effects; however, as this was a multi-country study judged to have low risk of bias on all
other criteria, it was not downgraded for this reason, and was considered high quality . In
2009, a meta-analysis identified 11 cohorts reporting on 5021 heterosexual couples and found
that there were no instances of HIV transmission in patients that were treated with ART and
had a viral load below 400 copies/ml (Attia, 2009). Several studies have recently indicated
that linked HIV transmission was not observed in serodiscordant couples who had condom-
less sex if the HIV-positive partner had a stably suppressed plasma viral load. As a result of
these ground breaking findings, the message that HIV-positive individuals with an
undetectable viral load could not transmit the virus to their partners was widely circulated.

The study reveals that the effectiveness of PrEP in preventing HIV transmission is dependent
upon an HIV-positive individual maintaining full virological suppression in plasma and the
exposed individual to take the PrEP prescription in full without missing and in combination
of the usage of condoms. Once an individual on ART is virally suppressed and maintains
good drug adherence, the risk of viral load rebound is very low. The findings in this study
provide new evidence for the “U = U” message and support the concept that HIV-positive
people who are adhering to treatment and exhibit a suppressed viral load do not transmit HIV
to HIV-negative sexual partners who are on PrEP. However, the message has not allowed
HIV-serodiscordant couples to engage in condom-less sexual acts. Furthermore, it can reduce
the burden of drug use during pregnancy without PrEP and reduce the potential risk of the
drugs. However, in some cases, couples are reluctant to disclose their HIV or serodiscordant
relationship status to families or communities and feel constrained to rely on each other for
social support in coping with HIV. PrEP offers potential relief from stress and may increases
trust within the relationship. Recognizing the issues these couples face enables physicians to
offer honest and non-judgmental preconception.

There were several limitations to the study. First, this study was conducted retrospectively by
case selection and was not randomized, so there was the potential of selection bias. Second,
the number of HIV-serodiscordant couples was small. A larger prospective study should be
conducted to evaluate the efficacy of PrEP use during natural conception among HIV-
serodiscordant couples.

5.2 Conclusion

In summary, the study examined whether PrEP use during natural conception was beneficial
in reducing the risk of HIV transmission among HIV-1-serodiscordant couples that have an
HIV-positive partner who has achieved long-term viral suppression. The study found no
cases of HIV seroconversion in the PrEP group. The results indicate that PrEP use during
natural conception may not be necessary in HIV-1-serodiscordant couples if the HIV-positive
partner has stably suppressed plasma viral loads. Furthermore, the findings provide new
evidence for the message of “U = U.” The decision to undergo PrEP during the process of
natural conception

22
in HIV-serodiscordant couples should be based on sustained viral suppression in the HIV-

positive partner.

5.3 Recommendations

 A cohort study to be conducted which will compare those who are PrEP to those who
are not taking PrEP in order to assess the effectiveness of PrEP.
 A further study to be conducted on the effective of PrEP in key population such as sex
workers.
 A comparative study to be conducted between voluntary medical male circumcision
on (vmmc) and PrEP to observe which one is more effective.
 A qualitative study to be conducted on the effective of PrEP
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 27

5. Study period

The will be conducted over …………………….

Ghantt Chart

Table 2. Activity timeline for the study

Septe-

30th Oct

,20

Proposal

completion

Graduate

forum

Ethical

Approval

Data

collection

Data

analysis

Thesis

Writing

Thesis
Defense

Publication

28
Appendices
Appendix 1; Budget breakdown for the study

No ITEM QUANTITY AMOUNT

1 Study Nurse 1 x k5000 K4000

2 Checklist 120 K500

3 Pens 1 box K50

Total Amount K4550

 29

Appendix 2: Data Collection Tool- Checklist

TITLE: The uptake and clinical outcomes of Pre-exposure Prophylaxis in sero-

discordant populations at the University Teaching Hospital, Lusaka Zambia.

Patient ID#: __________________________

Facility #: ____________________________

1. Age: _______ years

2. Marital Status
Married

3. Employment Status

Employed Unemployed

4. Education Attainment

No Education Primary Level Secondary Level

Tertiary Level

5. PrEP start date: D D M M Y Y Y Y

Regimen: Tenofovir/Emtricitabine

6. Number of Sexual Partners:

1 2-5 >5
7. Use of Condoms
Yes No
8. History of STI :
Yes No

Vaginal Discharge Genital Ulcer Genital Warts

9. Type of STI:
 Syphilis Gonorrhoea Chlamydia T. vaginalis

HSV

30

10. Treatment Received if Known:

Doxycycline Ceftriaxone Benzedrine Penicillin

Azithromycin Ciprofloxacin Don’t Know

11. RPR
RPR: Positive Negative

31