Maternal Health Studies

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 is a single-arm longitudinal study that will offer daily oral tenforvir/emtricitabine (TDF/FTC) as a pre-exposure prophylaxis for periconception. We aim to enrol 350 HIV-uninfected women in KwaZulu Natal, South Africa, who report personal or partner plans for pregnancy with an infected or unknown serostatus partner. Women will have the option to take PrEP during pregnancy. PrEP is offered as part of a safer conception package inclusive of couples-based HIV counselling and testing (CHCT), antiretroviral therapy (ART) for the infected partner, treatment for STIs and safer conception strategies, such as, limiting sex without condoms to peak fertility. The study commenced recruitment in 2017. Over three-hundred women are currently participating in the study, and recruitment is scheduled to be completed in early 2020.

A sub-study investigating sexually transmitted infections will commence within the next couple of weeks. Participants from the main PrEP Safer Conception for Women study will be invited to participate. The sub-study will present 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
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 will enrol 500 pregnant women, living with HIV and diagnosed during the current pregnancy.  Participant will be followed up over a period of two years. Field work  commenced in February 2018 and enrolment will be completed in 2020.

 

 

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

 

 

Completed Maternal Health Projects

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