Assessing Male Partner Engagement in HIV Testing Using Partner-notification Slip Plus Oral HIV Self-testing Kit Among Male Partners of HIV-negative Pregnant Women.
Phase: NA
Conditions: HIV Infections
Sponsor: University of North Carolina, Chapel Hill

 
Brief Title: Male Partner Engagement in HIV Testing Using Partner-
notification Slip Plus Oral HIV Self-testing Kit 
 
 
 
 
NCT number NCT07488221 
Document Date 01/07/2019 
 

 
 
 
 
 
 
Title:  Assessing male partner engagement in HIV testing using partner-
notification slip plus oral HIV self-testing kit among male partners of HIV-
negative pregnant women  
 
 
 

Contents 
Personnel and Institutions ........................................................................................................................... 1 
Abstract ........................................................................................................................................................ 2 
Background and Justification ....................................................................................................................... 2 
Literature Review ......................................................................................................................................... 3 
Hypotheses ................................................................................................................................................... 3 
Specific Aims/Study Objectives ................................................................................................................... 3 
Methodology ................................................................................................................................................ 4 
Study Design ............................................................................................................................................. 4 
Study Setting ............................................................................................................................................ 4 
Study Population ...................................................................................................................................... 4 
Study Procedures ..................................................................................................................................... 5 
Data Collection and Management ........................................................................................................... 5 
Sample Size ............................................................................................................................................... 6 
Data Analysis ............................................................................................................................................ 6 
Confidentiality/Ethics ................................................................................................................................... 7 
Confidentiality Assurance ........................................................................................................................ 7 
Risks .......................................................................................................................................................... 7 
Benefits ..................................................................................................................................................... 7 
Dissemination of Results .............................................................................................................................. 8 
Work Plan ..................................................................................................................................................... 8 
Budget ........................................................................................................................................................... 9 
References .................................................................................................................................................. 10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Page 1 of 14 
 
Personnel and Institutions 
 
Principal Investigator 
Maganizo B. Chagomerana, MS, PhD 
Head of Manuscript and Analysis Unit, 
University of North Carolina Project – 
Malawi, 
Tidziwe Centre, 
Private Bag A-104, 
Lilongwe, Malawi. 
Mobile (Malawi): +265-996-457-968 
Email: mchagomerana@unclilongwe.org 
 
Co-Investigators 
Mina C. Hosseinipour, MD, MPH 
Professor, Dept. of Medicine,  
University of North Carolina, Chapel Hill 
Chief Scientific Officer, UNC Project-Malawi, 
Tidziwe Centre, 
Private Bag A-104 
Lilongwe, Malawi 
Mobile (Malawi): +265-888-202-153 
Email: mina_hosseinipour@med.unc.edu  
 
Nora E. Rosenberg, MSPH, PhD 
Assistant Professor, Dept. of Health 
Behavior, 
Gillings School of Global Public Health 
University of North Carolina, Chapel Hill 
Tel: 919-602-8499 
Email: nrosenbe@email.unc.edu 
 
William C. Miller, MD, PhD, MPH 
Professor, Division of Epidemiology 
College of Public Health,  
The Ohio State University 
841 Neil Avenue, 302 Cunz Hall Columbus,  
OH 43210, USA  
Tel: +1 614-292-2516  
Email: miller.8332@osu.edu 
 
 
 
 
 
Irving F. Hoffman, PA, MPH 
Professor, Dept. of Medicine,University of 
North Carolina, Chapel Hill 
International Director, UNC Project-Malawi 
Tidziwe Centre, 
Private Bag A-104 
Lilongwe, Malawi 
Mobile (Malawi): +265-888-846-526 
Email: irving_hoffman@med.unc.edu  
 
Mitch M. Matoga, MBBS, MSc 
University of North Carolina Project– 
Malawi, 
Tidziwe Centre, 
Private Bag A-104, 
Lilongwe, Malawi. 
Mobile (Malawi): +265-999-511-726 
Email: mmatoga@unclilongwe.org 
 
 

 
Page 2 of 14 
 
Abstract 
In Malawi, and other sub-Saharan Africa (SSA) countries with high HIV burden, HIV testing 
uptake among men is lower compared to women. New interventions are being sought to 
encourage men to go for HIV testing. Through this study, we will assess if giving a notification 
slip plus HIV Self-testing kit to HIV-negative pregnant women with syphilis attending antenatal 
care can increase the number of men reporting for HIV testing compared to giving the women a 
notification slip only (standard of care). The objectives of this protocol are: (1) Compare the 
acceptability of male partners’ engagement in HIV testing using partner-notification slip plus 
oral HIV Self-test to partner-notification slip only among male partners of HIV-negative 
pregnant women with syphilis; (2) Identify demographic and sexual behavior factors associated 
with male partners’ return to clinic for HIV counselling and testing;  and (3)  Evaluate if using 
partner-notification slip plus HIV self-testing among HIV-uninfected pregnant women is 
associated with any social harm. Results are expected to inform if HIV self-testing for partners 
of HIV-negative pregnant women with syphilis can be incorporated in antenatal care.  
 
Background and Justification 
Despite the increasing campaign for HIV testing in sub-Saharan Africa, HIV testing uptake 
among men remains lower than among women. The tendency of men not to seek HIV testing 
and counseling (HTC)1-5 has resulted in poor outcomes along the HIV-care cascade such as low 
rate of ART initiation6-9 and poor retention in care.10 It is therefore important that new 
strategies to encourage men seek HIV testing are developed and implemented.  
 
Similarly, male partner engagement in Malawi’s antenatal care (ANC) program remains poor11,12 
although male partner engagement in antenatal care-seeking of their HIV-infected female 
sexual partners is associated with marked improvements in maternal and infant outcomes.12-14 
As a standard of care in Malawi, all pregnant women attending ANC are tested for HIV and 
syphilis (pregnant women with syphilis run the risk of severe fetal anomalies and miscarriages).  
Pregnant women who test positive for HIV are encouraged to bring their partners for HIV 
counselling and testing. If the pregnant woman is diagnosed with syphilis, she is given partner-
notification slip inviting their male sexual partners to come to clinic for syphilis testing and 
treatment services.  
 
HIV self-testing (HIVST) is an emerging approach to HIV testing. HIVST is a process in which 
individuals collect their own specimen, perform the test and interpret the results.1 If reactive, 
the results need to be confirmed through additional testing by a trained provider. HIVST was 
highly acceptable to men in Malawi.15,16 If well implemented in ANC, HIVST has the potential to 
increase male engagement in HIV counselling and testing.17  
 
However, partner-notification slip plus oral HIVST for sexual partners of pregnant women with 
syphilis attending ANC has never been tried in Malawi. By engaging both sexual partners 

 
Page 3 of 14 
 
through partner-notification slip plus oral HIVST, the strategy can reduce the risk of syphilis and 
HIV acquisition or transmission, and subsequent vertical transmission. 
Literature Review 
Pregnant women are at higher risk of acquiring HIV than their non-pregnant counterparts.18,19 
Biologically, pregnant women are more vulnerable to acquire HIV due to hormonal and 
immunological changes.20-24 Additionally, behavioral factors such as condomless sex during 
pregnancy or breastfeeding and if male partners seek other sexual partners during pregnancy 
or early days of postpartum increases women susceptibility to HIV infection. Sexually 
transmitted infections during pregnancy, including syphilis, are associated with increased risk of 
HIV infection.25-27 To avert HIV infections among pregnant women, it is important to engage 
both the pregnant women and their sexual partners in programs that reduce the risk of HIV 
acquisition and transmission.  
 
Besides increasing the likelihood of exposure to HIV, sexually transmitted diseases such as 
syphilis are very harmful in pregnancy. Fetus of mothers’ with maternal syphilis are at risk of 
contracting congenital syphilis that can lead to fetal anomalies and miscarriages.28-30 If the 
sexual partners of pregnant women are not tested and treated for syphilis, the pregnant 
women who have been treated for syphilis are still at risk for new syphilis infection from their 
partners. Encouraging sexual partners of pregnant women with syphilis come to the clinic for 
syphilis testing and treatment may protect both the pregnant woman and the fetus from 
syphilis re-infection and infection respectively.  
 
Diagnosis of sexually transmitted infection during pregnancy is an indicator of exposure to 
someone who is at risk of acquiring and transmitting other STI including HIV. Pregnant women 
who acquire HIV during pregnancy have acute/early HIV infection (AHI). Women with AHI have 
high levels and are more likely to transmit HIV to their infants than mothers with established 
HIV-infection.31-33 Unfortunately, HIV incidence among pregnant and breastfeeding women is 
not rare in sub-Saharan Africa, with reported incidence as high as 7% in a study conducted in 
multiple countries in Southern Africa. To prevent mother-to-child transmission of HIV, HIV-
uninfected pregnant women need to be protected from exposure to HIV. When properly 
implemented, HIV testing in male partners of HIV-uninfected pregnant women will minimize 
the likelihood of exposure to HIV during pregnancy. 
Hypotheses  
The overarching hypothesis of this study is that including oral HIV self-testing will increase HIV 
testing in male partners and decrease the likelihood of pregnant women exposure to HIV.  
Specific Aims/Study Objectives 
This study has three specific aims related to male partners of HIV-negative women engagement 
in HIV testing. These are described below: 
 
Aim 1: Compare the acceptability of male partners’ engagement in HIV testing using partner-
notification slip plus oral HIVST to partner-notification slip only among male partners of HIV-

 
Page 4 of 14 
 
negative pregnant women with syphilis. We will compare the partner-notification slip plus oral 
HIVST intervention to partner-notification slip only (standard of care) for increasing the 
proportion of male partners reporting to clinic and  proportion of male partners  testing for HIV. 
  
Aim 2: Identify demographic and sexual behavior factors associated with male partners’ 
return to clinic for HIV counselling and testing. We will compare the characteristics of male 
partners in the intervention arm to the characteristics of those in the standard of care arm to 
identify factors associated with male partner involvement in HIV testing and counselling. 
 
Aim3: Evaluate if using partner-notification slip plus HIV self-testing among HIV-uninfected 
pregnant women is associated with any social harm. We will analyse transcripts and 
structured observation memos using content analysis methodology to identify major themes 
using established qualitative research methods including principles of triangulation, negative 
case analysis, and respondent validation. 
 
Methodology 
Study Design 
This pilot study is a two-arm un-blinded randomized control trial of HIV-negative pregnant 
women with syphilis attending ANC. Women will be randomized to Standard of Care (SOC) or to 
an intervention arm. In the SOC arm, women will be given a partner notification slip inviting 
their male sexual partners for syphilis testing and treatment. Male sexual partners for women 
in SOC who report to the clinic will be invited to have an HIV test as well. The women in the 
intervention arm will be given oral HIVST kit for their partner and partner-notification slip 
inviting their sexual partners for syphilis test and a confirmatory HIV test.  
 
The main outcome will be the proportion of males who will show up to the clinic for HIV 
counselling and testing within 30 days of issuance of the partner notification slip. All 
participants will be actively followed up telephone until the male partner shows up to the clinic 
or 30 days elapses. 
 
Study Setting 
The study will be conducted at Bwaila District Hosptial. Bwaila District Hospital is a large 
maternity hospital serving the greater Lilongwe catchment area. Within Bwaila ANC, women 
are routinely screened for Syphilis and HIV infection using opt-out individual HIV testing and 
counselling.  
 
Study Population 
This study will comprise of all HIV-negative pregnant women with syphilis attending ANC at 
Bwaila District Hospital in Lilongwe, Malawi. Pregnant women will be eligible to participate if 
they meet the following criteria: 
Inclusion Criteria  
• HIV-negative with syphilis  

 
Page 5 of 14 
 
• >18 years old or 15-17 years old and married (emancipated minors per Malawi law)  
• Available and willing to be contacted by phone within the next 30 days 
• Part of a heterosexual relationship for >3 months and expects the sexual partner to be 
able to come to Bwaila in the next 30 days 
• Able and willing to provide informed consent 
 
Exclusion criteria 
Any condition that in the opinion of the study investigator would compromise the ability of the 
prospective participant to provide informed consent, undergo study procedures safely, or 
would prevent proper conduct of the study. 
 
Study Procedures 
Study staff will maintain a screening log with documented reasons for non-eligibility. Women 
interested in participating will be consented into the study, administered a brief survey, and 
randomized to one of the two study arms. Women in both arms will then be provided with 
partner-notification slip and encouraged to bring male partners to Bwaila for syphilis testing 
and treatment. The partner-notification slip will contain a unique identifier for the female 
participant. Women in both arms will be asked to provide phone number(s) through which they 
can be contacted. 
 
In addition to partner-notification slip, women in the intervention arm will be given oral HIVST 
kit for their partner that will include manufacturer-provided instructions for use. Women in the 
intervention arm will be trained on how to conduct the Self-test and will be informed on the 
performance and limitations of the product. They will also be given contact details and 
information about HIV testing services if uncertain about how to correctly perform the self-test 
or interpret the self-test result. The same information will be included in a study brochure that 
they will take home to the male partners.  
 
Male partners for women in both arms who report to the clinic will be offered syphilis and HIV 
counseling and testing. Male partners for women in the intervention arm with a reactive HIV 
self-test result will be offered confirmatory HIV testing. If the partners for women in both arms 
have confirmed HIV-positive diagnosis, they will be linked to HIV treatment and care. All 
partners for women in both arms with a non-reactive self-test result will be advised to retest 
later if there is a possibility that they were exposed to HIV in the preceding six weeks, or if they 
are at high ongoing HIV risk. 
 
The compensation amount for participants will be consistent with other study incentives in this 
setting ($10).  
 
Data Collection and Management 
Qualitative data 
We will conduct approximately 10 in-depth interviews with health-care and 10 in-depth 
interviews with mothers who received the intervention. During the interviews, we will use a 

 
Page 6 of 14 
 
semi-structured questionnaire and all interviews will be tape-recorded and later transcribed 
from the local language (Chichewa) to English.  
 
Quantitative data 
Study staff will be responsible for data collection. Clinic-based staff will screen and consent 
male and female participants and administer surveys.  Participant health information will be 
recorded on study case report forms (CRFs). All study documents including consent forms and 
CRFs will be stored in locked filing cabinets. A trained data entry clerk will be responsible for 
entering data into a password protected Microsoft Access database. All the data entered will be 
uploaded to a UNC Project server at the end of each working day for backup 
 
Sample Size 
We will consecutively enroll HIV-negative pregnant women with syphilis until we reach a 
convenient total sample of 200 women, with 100 women randomized to each arm. Assuming 
partner-notification slip uptake of 30% among pregnant women with syphilis, evaluating 200 
women will give us 83% power to detect a 20% difference in proportion of male partners 
reporting to clinic between women randomized to SOC and those randomized to the 
intervention.    
 
Data Analysis 
Aim 1: Compare the acceptability of male partners’ engagement in HIV testing using partner-
notification slip plus oral HIVST to partner-notification slip only among male partners of HIV-
negative pregnant women with syphilis. The main outcomes for this aim will be: 1) number 
and proportion of male partners testing for HIV. 2) Median time from issuance of notification 
slip to male partner return to clinic. We will calculate the proportion and the corresponding 
95% confidence interval (CI) of male partners coming to clinic. We will also calculate the median 
and the interquartile range of the time between issuance of partner-notification slip and the 
return of the male partner to clinic. Two-sample test of proportion and Wilcoxon ranksum test 
will be used to compare differences in proportion of male partners testing for HIV and 
differences in median time to return to clinic, respectively. 
 
Aim 2: Identify demographic and sexual behavior factors associated with male partners’ 
return to clinic for HIV counselling and testing. We will identify the factors associated with 
male-partner involvement in HIV counselling and testing using a questionnaire that will be 
administered to the pregnant women. We will use numbers and proportion (for categorical 
variables), and means or medians as appropriate (for continuous variables) to describe the 
characteristics of our population. Log-binomial regression models will be used to estimate both 
unadjusted and adjusted risk ratios and their corresponding 95% CI.  
 
Aim3: Evaluate if using partner-notification slip plus HIV self-testing among HIV-uninfected 
pregnant women is associated with any social harm. We will conduct a qualitative analysis of 

 
Page 7 of 14 
 
in-depth interviews transcripts and research memos from structured observations. To identify 
major and minor themes that explain those patterns, we will analyse transcripts and structured 
observation memos using content analysis methodology and appropriate analytical software. In 
this analysis, we will apply established qualitative research methods including principles of 
triangulation, negative case analysis, and respondent validation. 
Confidentiality/Ethics 
 
Confidentiality Assurance 
Sensitive information will be collected from both female and male participants. Measures will 
be taken to ensure this information is not shared between partners. The information on the 
notification slip will not disclose that the woman has syphilis. It will simply state that they need 
to report to the clinic for health information.  
 
Both male and female participants will be assigned a study ID number. This number will be 
linked to the participant name and medical record at the antenatal clinic only through a 
separate log book that will be kept in a separate locked file. Data will be double-entered into a 
password protected Microsoft Access database by a trained data entry clerk. Only the study 
staff will be able to link the medical record that has the participant name on it with study 
information that has the study ID number on it. At the conclusion of the study, this link 
between the name and number will be destroyed. Maganizo Chagomerana, PhD, Principal 
Investigator, will be responsible for the data and can be reached at +265-99-645-7968. 
 
No subjects will be identified in any report or publication about this study.  In some cases, 
information in this research study could be reviewed by representatives of the University of 
North Carolina, research sponsors, or Malawi government agencies for purposes such as quality 
control or safety.    
 
Risks 
Participants may feel embarrassed to answer questions about sexual behavior.  They can refuse 
to answer any questions at any time. During the HIV test, participants may feel discomfort 
when blood is drawn.  They may also feel dizzy or faint, or experience bruising or swelling at the 
blood drawing site.  However, this is part of standard of care for HIV counseling and testing. 
Risk is minimal. Participants may become worried or anxious while waiting for HIV test results. 
Trained counselors will be available to help participants deal with these feelings either at the 
clinic or through phone. HIV partner notification may cause social, economic, legal or physical 
harm but these harms are rare. Our team will do everything in our power to help them resolve 
these problems if they arise.  We will also systematically ask all female participants through 
telephone if these problems have occurred.  
 
Benefits 
The benefits to females from being in this study are to help notify sexual partners that they may 
have been exposed to syphilis.  This study may help male participants learn their syphilis and 

 
Page 8 of 14 
 
HIV status. It will help couples learn each other’s HIV and syphilis status. If the male partner has 
syphilis, he will be able to get treatment. If the male partner is HIV-infected, he will be linked to 
HIV care or treatment. If the couple is HIV-discordant, they may be able to use behavioral 
prevention measures to remain HIV-uninfected.  Malawi may benefit from the results of this 
research by learning new knowledge about HIVST and understanding of HIVST within the 
Option B+ program.  
 
Dissemination of Results 
The results of the study will be presented at international scientific meetings and published in 
scientific journals.  The results will also be submitted to the NHSRC. The preliminary data 
collected in this study may lead to larger longitudinal studies that will enable us further 
evaluate the impact of partner notification plus HIV self-testing on male partners HIV testing.  
Work Plan 
Study Activity 
2018 
2019 
9 
10 11 12 1 
2 
3 
4 
5 
6 
7 
8 
9 
10 11 
Regulatory / IRB 
submission 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SOP development 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Staff training 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participants’ enrolment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data Analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dissemination of results 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Page 9 of 14 
 
Budget 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Budget justification: 
The specific costs for this project include salary support for HIV Counsellor at 100% effort for 1 
year. ORAquick HIV Self-test kits will be purchased and given to women who will be randomized 
to the partner-notification plus oral HIVST arm. We will buy airtime to make follow-up 
telephone calls to clients. We will also pay for printing materials for partner-notification slips 
and instructions for self-test in Chichewa. The total budgeted for this project is $11,920. 
 
 
 
Item 
Amount 
# Units 
Units 
Total 
Personnel 
 
 
 
 
HIV Counselor 
$2,400 
1 
Year 
$2,400 
Supplies 
ORAquick Test kit 
$50 
100 
Packet 
$5,000 
Airtime 
$300 
          1  Year 
$300 
Printing documents 
$5 
200 
Couple 
$1,000 
Participant incentives 
$10 
200 
Couple 
$2,000 
Subtotal 
  
  
  
$10,700 
NHSRC percentage 
$10,700 
0.1 
application  
$1,070 
NHSRC fee 
$150 
1 
application  
150 
NHSRC subtotal 
  
  
  
$1,220 
 
 
 
 
 
Total  
 
 
 
$11,920 

 
Page 10 of 14 
 
References 
1. 
Guidelines on HIV Self-Testing and Partner Notification: Supplement to Consolidated 
Guidelines on HIV Testing Services. Geneva: World Health Organization 2016.; 2016. 
2. 
Hensen B, Taoka S, Lewis JJ, Weiss HA, Hargreaves J. Systematic review of strategies to 
increase men's HIV-testing in sub-Saharan Africa. Aids. Sep 10 2014;28(14):2133-2145. 
3. 
Maughan-Brown B, Lloyd N, Bor J, Venkataramani AS. Changes in self-reported HIV 
testing during South Africa's 2010/2011 national testing campaign: gains and shortfalls. 
Journal of the International AIDS Society. 2016;19(1):20658. 
4. 
WHO/UNAIDS/UNICEF. Global Response to HIV/AIDS: Epidemic Update and Progress 
towards Universal Access. 2011. 
5. 
UNAIDS. The Gap Report. 2014. 
6. 
Bastard M, Nicolay N, Szumilin E, Balkan S, Poulet E, Pujades-Rodriguez M. Adults 
receiving HIV care before the start of antiretroviral therapy in sub-Saharan Africa: 
patient outcomes and associated risk factors. Journal of acquired immune deficiency 
syndromes. Jul 25 2013. 
7. 
Sloan DJ, van Oosterhout JJ, Malisita K, et al. Evidence of improving antiretroviral 
therapy treatment delays: an analysis of eight years of programmatic outcomes in 
Blantyre, Malawi. BMC public health. 2013;13:490. 
8. 
Geng EH, Bwana MB, Muyindike W, et al. Failure to initiate antiretroviral therapy, loss to 
follow-up and mortality among HIV-infected patients during the pre-ART period in 
Uganda. Journal of acquired immune deficiency syndromes. Jun 1 2013;63(2):e64-71. 
9. 
Ndawinz JD, Chaix B, Koulla-Shiro S, et al. Factors associated with late antiretroviral 
therapy initiation in Cameroon: a representative multilevel analysis. The Journal of 
antimicrobial chemotherapy. Jun 2013;68(6):1388-1399. 
10. 
Weigel R, Estill J, Egger M, et al. Mortality and loss to follow-up in the first year of ART: 
Malawi national ART programme. Aids. Jan 28 2012;26(3):365-373. 
11. 
Mphonda S, Rosenberg NE, Kamanga E, et al. Assessment of Peer-Based and Structural 
Strategies for Increasing Male Participation in an Antenatal Setting in Lilongwe, Malawi. 
African Journal of Reproductive Health, Special Edition on HIV/AIDS. 2013;in press. 
12. 
Kalembo FW, Zgambo M, Mulaga AN, Yukai D, Ahmed NI. Association between Male 
Partner Involvement and the Uptake of Prevention of Mother-to-Child Transmission of 
HIV (PMTCT) Interventions in Mwanza District, Malawi: A Retrospective Cohort Study. 
PloS one. 2013;8(6):e66517. 
13. 
Myer L, Duong J, Zhang Y, Abrams E, Carter R. Co-enrollment of HIV+ Family Members in 
Care Is Associated with Improved Outcomes for Women on ART: A Cohort Study. 
Conferences on Retroviruses and Opportunistic Infections 2013;1105. 
14. 
Aluisio A, Richardson BA, Bosire R, John-Stewart G, Mbori-Ngacha D, Farquhar C. Male 
antenatal attendance and HIV testing are associated with decreased infant HIV infection 
and increased HIV-free survival. Journal of acquired immune deficiency syndromes. Jan 1 
2011;56(1):76-82. 
15. 
Choko AT, Desmond N, Webb EL, et al. The uptake and accuracy of oral kits for HIV self-
testing in high HIV prevalence setting: a cross-sectional feasibility study in Blantyre, 
Malawi. PLoS medicine. Oct 2011;8(10):e1001102. 

 
Page 11 of 14 
 
16. 
Choko AT, MacPherson P, Webb EL, et al. Uptake, Accuracy, Safety, and Linkage into 
Care over Two Years of Promoting Annual Self-Testing for HIV in Blantyre, Malawi: A 
Community-Based Prospective Study. PLoS medicine. Sep 2015;12(9):e1001873. 
17. 
Kumwenda M, Munthali A, Phiri M, et al. Factors shaping initial decision-making to self-
test amongst cohabiting couples in urban Blantyre, Malawi. AIDS and behavior. Jul 
2014;18 Suppl 4:S396-404. 
18. 
Taha TE, Dallabetta GA, Hoover DR, et al. Trends of HIV-1 and sexually transmitted 
diseases among pregnant and postpartum women in urban Malawi. AIDS (London, 
England). Jan 22 1998;12(2):197-203. 
19. 
Gray RH, Li X, Kigozi G, et al. Increased risk of incident HIV during pregnancy in Rakai, 
Uganda: a prospective study. The Lancet. 2005;366(9492):1182-1188. 
20. 
Michael CW, Esfahani FM. Pregnancy-related changes: a retrospective review of 278 
cervical smears. Diagnostic cytopathology. Aug 1997;17(2):99-107. 
21. 
Brabin L. Interactions of the female hormonal environment, susceptibility to viral 
infections, and disease progression. AIDS patient care and STDs. May 2002;16(5):211-
221. 
22. 
Beagley KW, Gockel CM. Regulation of innate and adaptive immunity by the female sex 
hormones oestradiol and progesterone. FEMS immunology and medical microbiology. 
Aug 18 2003;38(1):13-22. 
23. 
Rodriguez-Garcia M, Patel MV, Wira CR. Innate and adaptive anti-HIV immune 
responses in the female reproductive tract. J Reprod Immunol. Mar 2013;97(1):74-84. 
24. 
Wira CR, Fahey JV, Rodriguez-Garcia M, Shen Z, Patel MV. Regulation of mucosal 
immunity in the female reproductive tract: the role of sex hormones in immune 
protection against sexually transmitted pathogens. American journal of reproductive 
immunology (New York, N.Y. : 1989). Aug 2014;72(2):236-258. 
25. 
Businge CB, Longo-Mbenza B, Mathews V. Risk factors for incident HIV infection among 
antenatal mothers in rural Eastern Cape, South Africa. Global health action. Jan 
2016;9(1):29060. 
26. 
Rosenberg NE, Graybill LA, Wesevich A, et al. Individual, Partner, and Couple Predictors 
of HIV Infection among Pregnant Women in Malawi: A Case-Control Study. AIDS and 
behavior. Oct 30 2017. 
27. 
Msuya SE, Mbizvo E, Hussain A, Uriyo J, Sam NE, Stray-Pedersen B. HIV among pregnant 
women in Moshi Tanzania: the role of sexual behavior, male partner characteristics and 
sexually transmitted infections. AIDS research and therapy. Oct 17 2006;3:27. 
28. 
Ratnam AV, Din SN, Hira SK, et al. Syphilis in pregnant women in Zambia. The British 
journal of venereal diseases. Dec 1982;58(6):355-358. 
29. 
Schulz KF, Cates W, Jr., O'Mara PR. Pregnancy loss, infant death, and suffering: legacy of 
syphilis and gonorrhoea in Africa. Genitourinary medicine. Oct 1987;63(5):320-325. 
30. 
Newman L, Kamb M, Hawkes S, et al. Global estimates of syphilis in pregnancy and 
associated adverse outcomes: analysis of multinational antenatal surveillance data. PLoS 
medicine. 2013;10(2):e1001396. 
31. 
Palasanthiran P, Ziegler JB, Stewart GJ, et al. Breast-feeding during primary maternal 
human immunodeficiency virus infection and risk of transmission from mother to infant. 
The Journal of infectious diseases. Feb 1993;167(2):441-444. 

 
Page 12 of 14 
 
32. 
Van de Perre P, Simonon A, Msellati P, et al. Postnatal transmission of human 
immunodeficiency virus type 1 from mother to infant. A prospective cohort study in 
Kigali, Rwanda. The New England journal of medicine. Aug 29 1991;325(9):593-598. 
33. 
Humphrey JH, Marinda E, Mutasa K, et al. Mother to child transmission of HIV among 
Zimbabwean women who seroconverted postnatally: prospective cohort study. BMJ 
(Clinical research ed.). 2010;341:c6580.