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 enrolled 330 HIV-uninfected women in KwaZulu Natal, South Africa, who reported personal or partner plans for pregnancy with an infected or unknown serostatus partner. 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. Women have the option to take PrEP during pregnancy.
This clinical trial commenced in 2017 and completed recruitment in January 2020. The study team is currently conducting follow-up visits, telephonically and in person. In-depth interviews are also underway. The DSMB for this clinical trial have found it to be safe and important to continue until study completion. This clinical trial was audited by SAHPRA in 2019 and found to adhere to satisfactory ethical standards for conducting a clinical trial in South Africa.
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 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)|
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 target to enrol 500 pregnant women, living with HIV. Participant are followed up over a period of two years. Field work commenced in February 2018 and enrolment ended on 20 March 2020 having enrolled 472 participants. Participants are being followed up and some exited.
An ancillary study investigating the incidence of HIV drug resistance among postpartum Women Living with HIV and failing first-line ART commenced on 5 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|