Maternal Health Studies

Acceptability of combination treatment for cervical precancer among South African Woman living with HIV (Act 1):

Despite the availability of cost-effective prevention strategies, cervical cancer remains the second most common cancer among women worldwide. The disparity in cervical cancer incidence and mortality between low- and middle-income countries (LMICs) and industrialized countries can largely be attributed to differences in healthcare access, particularly for cancer screening and treatment. Standard surgical treatments (excision or ablation) for pre-invasive cervical disease are less effective in women living with HIV, and 20-40% of HIV-infected women will experience a recurrence of disease after surgery. Wits MRU is assisting the Clinical HIV Research Unit (CHRU) in qualitative research  to understand HIV-infected women’s experiences and preferences regarding cervical cancer screening and pre-invasive cancer (CIN 2/3) treatment. The primary outcomes will include qualitative analysis of barriers to and facilitators of cervical screening and treatment within South Africa’s public sector, focusing on participants’ perspectives on topical therapy acceptability of combination treatment for CIN2/3.


Funder/Sponsor:NIH – National Institute of Health
Principal Investigators:

Dr. Carla Chibwesha (CHRU, UNC Global Woman’s Health)

Prof Mags Beksinska (Wits MRU), (Asc Prof Cecilia Milford Wits MRU)

Site:Helen Joseph Hospital, Johannesburg



Prospective Evaluation of Postpartum Engagement in HIV Care

The PEPEHC study aims to estimate the rate of attrition from HIV care and to identify factors associated with attrition form and retention in HIV care during postpartum period.  This study targeted  pregnant women, living with HIV.  Participant are  being followed up  for  a period of two years. Field work commenced in  2018 and enrolment ended on 20 March 2020 having enrolled 472 participants.  Participants are  currently being exited.

An ancillary study investigating the incidence of HIV drug resistance among postpartum Women Living with HIV and failing first-line ART commenced in August 2019. PEPEHC participants are invited to consent to HIV drug resistance testing at 12 months visit on all samples with a viral load >1000 and dried blood spots for Tenofovir DP levels. 


Funder/Sponsor:NIH – National Institute of Health (R01: MH112385-01)
Principal Investigators:Prof Jenni Smit
Site:PMMH Gateway Clinic
CollaboratorsMassachusetts General Hospital MGH and Harvard Medical School



Completed Maternal Health Projects

Safer Conception for Women Study – Understanding use of Periconception PrEP: The ZINK Study “Protect yourself before pregnancy”

Pre-exposure prophylaxis (PreP) use of oral tenofovir/emtricitabine (TDF/FTC) have been shown to offer protection against HIV acquisition in sero-discordant couples. PreP may offer HIV-negative women in endemic settings with an effective risk reduction strategy that will allow them to safely conceive if they are in sero-discordant relationships. Evaluating uptake of and adherence to antiretrovirals as pre-exposure prophylaxis in this population is crucial to understanding whether and how this novel prevention strategy should be incorporated into HIV-risk reduction packages for at- risk women planning or with pregnancy.

The PreP Safer Conception for Women study was a single-arm longitudinal study that  offered daily oral tenforvir/emtricitabine (TDF/FTC) as a pre-exposure prophylaxis for periconception.  The study enrolled its first participant in November 2017. A total of 330 participants were enrolled into the study, with the last participant exited in May 2021. In the unfortunate occurrence of the COVID-19 pandemic, the study was able to successfully follow-up participants through hybrid study visits where most of activities were conducted telephonically and participants came to site only for clinical study activities.

Following the completion of participants’ follow-up, dissemination and analysis of study findings are currently underway and had successfully completed disseminating findings to study participants in March 2022.

A sub-study investigating sexually transmitted infections commenced in December 2019. Participants from the main PrEP Safer Conception for Women study were invited to participate, of which 51 participants enrolled.  The sub-study presented participants with the opportunity to be tested and treated for active STI infections.


Funder/Sponsor:NIH/ Lynn Matthews, The University of Alabama at Birmingham, Department of Medicine.
Principal Investigators:Jenni Smit, (MRU) Lynn Matthews ( University of Alabama)
Site:MRU, Durban
Perinatal depression, stigma, social capital utilization and PMTCT adherence
The study explored the relationship of perinatal depression, stigma, and social capital utilization, and how these factors influence adherence to key PMTCT health behaviours among women.  In the first phase, a longitudinal study tested  a model of preventing mother-to-child transmission of HIV (PMTCT) adherence and in the second phase a behavioural intervention was  developed  and piloted which aimed to reduce perinatal depression and increase adherence to antiretroviral therapy as a primary outcomes, and reduce internalized stigma and increase  social capital utilization as secondary outcomes. We hypothesize that this work will be an essential component to increasing uptake of PMTCT services in resource limited settings.  The  intervention was completed and write of the study results is in progress.

Funder/Sponsor:National Institutes of Health via Massachusetts General Hospital
Principal Investigators:Dr C Psaros (Massachusetts General Hospital), Prof J Smit (MatCH Research)
Site:Department of Health Hospital, Durban

Postpartum depression (PND) and maternal-child behavioural and health outcomes in KwaZulu-Natal, South Africa
Investigating the underlying maternal vulnerabilities that disrupt maternal well-being is critical in understanding towards the development of context appropriate parenting and mental health interventions. We adapted and tested the effectiveness and cost-effectiveness of a caregiving and health promotion intervention to address modifiable risk factors of insecure attachment and poor psychosocial stimulation associated with disrupted caregiving. The intervention promoted gender transformative and responsive caregiving and attachment and psycho-social stimulation for infants, affected by HIV, of depressed mothers from low socio-economic backgrounds in KwaZulu-Natal. The  study sought to 1) determine prevalence of postnatal depression amongst 300 women living with and without HIV with very young infants in a public health clinic serving an urban, low-SES population in the Durban area, 2) examined correlates of postnatal depression, and 3) gained insight into maternal antecedent experiences with parenting (and being parented), as well as values and experiences regarding parenting. The study was completed in 2016.

Funder/Sponsor:HEARD, University of KwaZulu-Natal
Principal Investigators:Dr T Crankshaw (HEARD), Prof J Smit (MatCH Research)
Site:Department of Health Community Health Centre, Durban


Safer conception for HIV-infected men choosing to Conceive with At-Risk-Partners: Helping Men Have Healthy Babies (Piloting the intervention)
This project aimed to develop a safer conception intervention for HIV-infected men who choose to conceive with at-risk partners. The study had 3 phases. In Phase 1 we recruited HIV positive men from a clinic in Durban who reported desire to have a child in the next year with their HIV-uninfected or HIV status unknown partner. We conducted three focus group discussions in order to obtain feedback on our safer conception intervention for serodiscordant couples exploring perceived effectiveness, feasibility, and acceptability of intervention content, best approaches to maximize recruitment and retention and acceptability and feasibility of SMS messaging to record sexual behaviour. An open  Pilot study of the safer conception intervention was conducted and the study was completed in January 2018.

Funder/Sponsors:National Institutes of Health via Massachusetts General Hospital
Principal Investigators:Dr L Matthews (Massachusetts General Hospital ), Prof J Smit (MatCH Research)
Site:Durban Clinic
A Pilot study of a new device to reduce the rate of preterm birth and improve pregnancy outcomes: The SMART Diaphragm
The WHO estimates that every year, an estimated 15 million babies are born preterm (before 37 completed weeks of gestation), and this number is rising. Preterm birth is a global problem but more than 60% of preterm births occur in Africa and South Asia. Preterm birth complications are the leading cause of death among children under 5 years of age, responsible for nearly 1 million deaths in 2013. The SMART Diaphragm  was developed to detect early signs of preterm birth. This study is being conducted to find out whether the SMART Diaphragm can predict preterm birth earlier than any of our current methods. The SMART Diaphragm may be used in the future to monitor pregnancies for early signs of preterm birth. This would allow doctors to provide earlier treatment with better chances of delaying or preventing the preterm birth.

Formative research was  conducted in Durban and Kenya to determine views and opinions of the device. This will be followed by a clinical phase which will test the device itself.

Funder/Sponsor:University of California- San Francisco (UCSF), Bill and Melinda gates Foundation
Principal Investigators:Prof Larry Rand (UCSF)
Investigators:Prof J Smit, Dr Mags Beksinska (MatCH Research)
Site:Department of Health clinics/Hospital,  KwaZulu Natal