Socio-behavioral Studies

Trauma-related health behaviours and adverse birth outcomes among women living with HIV in South Africa

The goal is to examine PTSD (Post Traumatic Stress Disorder) symptoms and trauma related health risk behaviours as a potential pathway between trauma exposure and adverse birth outcomes among women living with HIV in South Africa and for this data to inform a future trauma-focused behavioural health intervention for pregnant women living with HIV. 

We will recruit 130 HIV-infected pregnant women from a large district hospital in KwaZulu Natal at the end of pregnancy.  A subset of the sample (n = 50) will undergo a blood draw to assess HIV RNA. About one to three months after the participant gives birth, they will be asked to return to go over their birth outcome data.

Qualitative In-Depth Interview will be conducted with (N=25) participants and 10-12 antenatal medical providers (or until thematic saturation is reached) to explore the role of trauma symptoms in the development and maintenance of risk behaviours, positive health behaviours, and for preferences for a trauma-informed intervention for pregnant women living with HIV (WLWH). The results will be used to identify targets for the development and testing of a culturally-informed intervention to reduce trauma symptomatology and trauma-related health risk behaviours.

 

Funder/Sponsor: CFAR – National Institutes of Health (US)
Principal Investigators:

Dr Elizabeth Waldron

Dr Christina Psaros – Massachusetts General Hospital

Prof Jenni Smit – Wits MRU

Site: WMRU – Durban

 

 

Identifying and addressing barriers to retention in the cervical cancer treatment cascade among women with HIV in South Africa

The purpose of this study is to develop and test the feasibility and acceptability of a patient-level intervention and provider toolkit to increase retention in care among women with HIV (WWH) who received high-risk abnormal cervical cytology screening test results.

Aim 1a: Explore structural-, community/relational-, and individual-level barriers and facilitators to follow-up appointment attendance and subsequent treatment among women with HIV (WWH) with a recent high-risk abnormal cervical cytology screening test result in Durban, SA.

Aim 1b: Explore provider awareness of the relationship between HIV and cervical cancer and perspectives on barriers to retention in care post-abnormal cervical cytology screening test result via individual qualitative interviews (n<8).  We started in October 2024 to recruit up to 30 women to complete the Aim 1a qualitative interviews, up to 8 providers to complete the Aim 1b qualitative interviews, and 8-10 women for the Aim 3 open pilot intervention.

 

Aim 2: Develop a brief patient-level intervention and provider toolkit to increase retention in care among WWH who received high-risk abnormal cervical cytology

Aim 3: Test the feasibility and acceptability of the intervention in an open pilot (n=8-10

 

Study title

Identifying and addressing barriers to retention in the cervical cancer treatment cascade among women with HIV in South Africa

Funder National Institutes of Health (US)
Principal and Co-Principal investigators

Dr Amelia Stanton – Boston University

Dr Christina Psaros – Massachusetts General Hospital

Prof Jenni Smit – Wits MRU

Site WMRU – Durban

 

Developing a Resiliency Intervention to Support Nurses Engaged in the Provision of HIV Care (Phase 2): The Qinisa (Strengthen) Study

This study will pilot test an adapted version of an existing stress management and resiliency-enhancing intervention (the Relaxation Response Resiliency Program; the 3RP) for nurses that care for PLWH in the public sector in SA, to test the feasibility and acceptability of all study procedures.

This phase involved a small proof-of-concept study (N = 8) which has been successfully completed. 

An intervention manual is being adapted to be implemented in a  randomized pilot study (N = 60) to test the feasibility and acceptability of the adapted intervention 

Additionally, this study will collect anonymous clinic client data on demographics, satisfaction with care, client-provider trust, and likelihood of returning to care (N=up to 250-400 surveys). We will also collect clinic-level data to understand how to measure client-related outcomes and clinic metrics of HIV care engagement, such as expected patient return rates/measures of retention, percentage of patients with suppressed viral load, frequency of viral load collection, and percentage of patients initiating second line treatment to best understand how to measure these variables in a larger trial testing the efficacy of the intervention.

Study title

Developing a Resiliency Intervention to Support Nurses Engaged in the Provision of HIV Care (Phase 2): The Qinisa (Strengthen) Study

Funder National Institutes of Health (US)
Principal and Co-Principal investigators

Dr Christina Psaros – Massachusetts General Hospital

Prof Jenni Smit – Wits MRU

Site National / Provincial

 

Nursing Resilience

 

Study title

Developing a resiliency intervention to support nurses engaged in the provision of HIV care (Phase I)

Study design  

This study will adapt, refine, and pilot test an existing stress management and resiliency-enhancing intervention (the Relaxation Response Resiliency Program; 3RP) for nurses providing HIV care in the public sector in SA. We will identify the ways in which the 3RP requires adaptation to meet the needs of nurses based on data collected from focus group discussions (FGDs) and adapt the intervention accordingly. We will enroll N=15-21 nurses to participate in FGDs (up to 3 groups of 5-7 nurses).

Funder

NIH –

Principal investigators

Dr Christina Psaros – Massachusetts General Hospital,

Prof Jenni Smit – Wits Maternal Adolescent and Child Health Research

Site

EThekwini clinics providing HIV care

 

AYAZAZI RIGHTS (Rapid Investigation of Gendered Health outcomes in the Time of SARS-CoV-2): Focusing on sexual and reproductive health among adolescents in South Africa.

This anonymous online data free mobile survey addresses knowledge gaps concerning adolescent experiences of COVID-19, public health responses and impacts on priority sexual, reproductive and mental health outcomes. Th study has two aims: (1) To measure adolescent attitudes towards, compliance with, and experiences (e.g., job loss) of COVID-19, public health and government responses (e.g., provision of social grants); (2) To assess the impacts of the COVID-19 response on key sexual, reproductive and mental health outcomes, including gender attitudes, beliefs and practices including gender-based violence, access to HIV testing, prevention (i.e. PrEP and condoms), and treatment services, contraceptive access, and experiences of depression and anxiety. The survey   commenced  in 2022 and aims to reach  2000 adolescents aged 16 – 24 in the eThekwini District, KZN.

Click here for list of resources

 

 

Funder/Sponsor: BC Children’s Hospital Foundation
Principal Investigator: Dr Mags Beksinska (MRU), Angela Kaida
Site: MRU, Durban

SURVEY LINK: https://ars.datafree.co/AyazaziRightsSurvey

 

 

Socio-behavioral Completed Studies

SOAR project

This evaluation study will assess the effectiveness of a community-based HIV prevention program in informal settlements within KwaZulu-Natal—one of four provinces where the programme is being carried out. The Community Responses intervention is a multifaceted behaviour change intervention using an adapted and scaled version of Stepping Stones. The intervention is designed to promote uptake of HIV and SGBV support services, while also promoting equitable gender norms and a positive enabling environment. The programme targets young men and women living in informal settlements. The Project SOAR evaluation will address a series of important research questions, such as what are the key factors within the informal settlement context that lead to HIV risk behaviours, what level of exposure to an intervention is needed to improve key outcomes, and how to best scale up group education models such as Stepping Stones. Building the global evidence base in this area is vital to improving outcomes related to HIV prevention and eliminating harmful gender norms and SGBV, especially in informal settlements.

 

Our Research: The study uses a cluster stepped-wedge evaluation design whereby 18 clusters (communities) are randomized to when they initiate the CR intervention. A cohort of approximately 1500 men (aged 18–35) and women (aged 18–24) in evaluation communities will be followed over the course of approximately 30 months. Survey interviews will be completed at baseline and at three additional time points at 7-month intervals. In addition, we will conduct qualitative interviews with programme implementers and a selection of study participants to gain a deeper understanding of the process, experiences, challenges, and benefits of adapting and scaling up the Stepping Stones intervention.

 

Research Utilization: This study aims to influence the achievement of two key objectives of the South Africa’s National Strategic Plan on HIV—addressing social and structural drivers of HIV and reaching all vulnerable populations with comprehensive services and interventions. To ensure research utilization of findings, the study team continuously engages with key local stakeholders at all stages of the study from inception to dissemination of findings, including the HIV prevention unit of the Department of Health in KwaZulu-Natal Province and nationally; implementers of community-based HIV activities, such as Centre for Communication Impact; and researchers at universities and institutes.

 

Project SOAR is a five-year (September 2014–September 2019) cooperative agreement funded by the President’s Emergency Plan for AIDS Relief and the U. S. Agency for International Development (Agreement No. AID-OAA-A-14-00060). Population Council leads the Project SOAR consortium in collaboration with Avenir Health, Elizabeth Glaser Pediatric AIDS Foundation, the Johns Hopkins University, Palladium, and The University of North Carolina at Chapel Hill.

Funder/Sponsor: President’s Emergency Plan for AIDS Relief, U. S. Agency for International Development
Principal Investigator: Dr. Julie Pulerwitz (Population Council), Site PI: Mags Beksinska
Site: MatCH Research Commercial City Site and communities in central Durban and Ugu
Collaborators: CCI (Centre for communication impact)

 

IPM Socio Behavioural Study
In-depth interviews (IDIs) and focus group discussions (FGDs) were conducted with female participants and IDIs with male partners of the participants in the IPM 027 Ring Study at sites across South Africa and Uganda. These interviews and discussions explored issues of adherence and acceptability of the vaginal ring.

In-depth interviews were also conducted in the IPM 032 study across 4 research centres in South Africa and Uganda, looking at cases of special interest (including non-adherent ring users, participants who fell pregnant or seroconverted during the study.

Funder/Sponsor: International Partnership for Microbicides (IPM)
Principal Investigator: Prof J Smit (MatCH Research Unit)
Site: MatCH Research main office

 

DIFFER: Diagonal Interventions to Fast-Forward Enhanced Reproductive Health
The “Diagonal Interventions to Fast Forward Enhanced Reproductive Health” (DIFFER) research project tests the hypothesis that combining vertical Sexual and Reproductive Health (SRH) interventions, such as services targeted to Female Sex Workers (FSW), with horizontal strengthening of health systems for SRH within existing health facilities, is synergistic, feasible, and likely to be more effective and cost-effective than providing them separately. In particular, the research activities will build capacity to implement interventions for FSW.  This multi-country study consists of a consortium of three African, one Indian and two European partners. The research activities are being undertaken in the African sites (Durban, South Africa; Mombasa, Kenya; and Tete, Mozambique) and in Mysore India.  The formative research  including a detailed situational and policy analysis informed the development of site and context-specific intervention packages to strengthen SRH services. This study is now in the intervention phase and a comprehensive evaluation will follow at the end of 2015.

Funder/Sponsor: The European Union
Principal Investigator: Prof J Smit (MatCH Research)
Site: MatCH Research Commercial City Site and community  in central Durban
Collaborators: University of Ghent – International Centre for Reproductive Health (UG-ICRH), Belgium, Ashodaya Samithi (Ashodaya), India, International Centre for Reproductive Health Association, Kenya (ICRH-K), International Centre for Reproductive Health Association Mozambique (ICRH-M), Lifeline, Durban

 

Safer conception for HIV-infected men choosing to Conceive with At-Risk-Partners: Helping Men Have Healthy Babies (Piloting the intervention)
This project aims to develop a safer conception intervention for HIV-infected men who choose to conceive with at-risk partners. The study has 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.

The study is currently in the planning phase and we are working on Phase 2, an Open Pilot study of the safer conception intervention. In Phase 3 we will conduct a pilot randomised controlled trial of the final safer conception intervention among men who want to have children with uninfected or unknown status partners.

 

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