# Integrating Trauma-Informed Research in Assessment of Young Women Engaged in HIV Cure Research (Post-Intervention Control) Trial with Analytical Treatment Interruption in Durban, South Africa

> **NIH NIH R21** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2023 · $421,815

## Abstract

7. PROJECT SUMMARY/ABSTRACT
Significance: HIV cure has emerged as a global research priority requiring the field to look beyond trials
conducted primarily in the US enrolling white men. Participation in cure research that includes prolonged complex
visit requirements and analytical treatment interruptions (ATIs) pose not only biological risk, but also social,
emotional, and ethical challenges. Understanding barriers to inclusion of key populations in high-HIV burden
low- and middle-income countries (LMICs), particularly challenges facing marginalized groups, is critical to
designing protocols that promote equitable enrollment of those in greatest need of innovations in HIV cure and
treatment. Women remain critically underrepresented in cure research globally. Despite representing 53% of
HIV infections worldwide, women represent only 12% of HIV cure research participants. Opportunity: To conduct
a socio-behavioral research (SBR) study to assess the experiences of young women enrolled in a first-in-Africa
all-female HIV cure trial that includes an ATI, in KwaZulu-Natal, South Africa. The trial will recruit from FRESH,
a clinical research site established in 2012 to enroll young women in HIV prevention, early treatment, and HIV
cure-related (post-intervention control) research. High intimate partner violence (IPV) is endemic in the region,
underscoring the need for trauma-informed research (TIR) and healing-centered design (HCD). Proposal: A SBR
study that includes a TIR framework and robust psychosocial support, with study interactions that take place at
key points during the trial, including at enrollment, prior to the first dose of study product, before pausing ART
during ATI, and after viral rebound. Longitudinal assessments will allow insight into decision making related to
trial participation, as well as potential worries around viral rebound, partner protections and disclosure. Inclusion
of open-ended discussions will allow sharing of challenges and give social context beyond triggers related to
trial participation. The study will also engage non-trial participants and clinical research staff contributing
perceptions about HIV cure and trial implementation challenges. Specific Aims: 1) Develop strategies to reduce
risks related to enrollment in an HIV cure trial, by characterizing the experiences of 25 trial participants, focusing
on their decision-making processes, trial-related concerns (e.g., disclosure, partner protections) and lived
experience at key points during the trial. 2) Gain an understanding of the social context and challenges of women
enrolled in an HIV cure trial, by quantifying trauma and IPV exposure, self-esteem, resilience, and mental health
(anxiety, depression) outcomes in 25 trial participants and 25 non-trial participants living with HIV, and 50 women
without HIV. 3) Develop recommendations for safe and ethical enrollment of women in future HIV cure trials in
Africa, based on input from 20 clinical research staff about...

## Key facts

- **NIH application ID:** 10761531
- **Project number:** 1R21MH132406-01A1
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** Karine Dube
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $421,815
- **Award type:** 1
- **Project period:** 2023-09-20 → 2026-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10761531

## Citation

> US National Institutes of Health, RePORTER application 10761531, Integrating Trauma-Informed Research in Assessment of Young Women Engaged in HIV Cure Research (Post-Intervention Control) Trial with Analytical Treatment Interruption in Durban, South Africa (1R21MH132406-01A1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10761531. Licensed CC0.

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