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 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)|
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|
|Collaborators||Massachusetts General Hospital MGH and Harvard Medical School|
Completed Maternal Health Projects
Perinatal depression, stigma, social capital utilization and PMTCT adherence
|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
|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)
|Funder/Sponsors:||National Institutes of Health via Massachusetts General Hospital|
|Principal Investigators:||Dr L Matthews (Massachusetts General Hospital ), Prof J Smit (MatCH Research)|
A Pilot study of a new device to reduce the rate of preterm birth and improve pregnancy outcomes: The SMART Diaphragm
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|