Evidence map›Paper›PMID 41685863›Full record

Trial reportJournal of the International Association of Providers of AIDS Care

Stress and Coping During an HIV Cure-Related Trial with an Analytical Treatment Interruption: A Qualitative Assessment of the Experiences of Young Women in Durban, South Africa.

Ali Ahmed, Miranda Hill, Krista L Dong, Mzwakhe Wiseman Ngcobo, Ayanda Zulu, Ntombifuthi Langa, Luyanda Maphalala, Vanessa Pillay, Maud Mthembu, Whitney Tran and 4 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the International Association of Providers of AIDS Care. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05281510 (A Phase 2a Study to Evaluate the Safety and Tolerability of a Regimen of Dual Anti-HIV Envelope Antibodies, VRC07-523LS and CAP256V2LS, in a Sequential Regimen With a TLR7 Agonist, Vesatolimod, in Early Antiretroviral-Treated HIV-1 Clade C-Infected Women), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05281510 phase2completednot on this map

A Phase 2a Study to Evaluate the Safety and Tolerability of a Regimen of Dual Anti-HIV Envelope Antibodies, VRC07-523LS and CAP256V2LS, in a Sequential Regimen With a TLR7 Agonist, Vesatolimod, in Early Antiretroviral-Treated HIV-1 Clade C-Infected Women

TypeinterventionalSponsorGilead SciencesRan2022 to 2025Enrolled20ConditionsHIV-1-infectionArmsVesatolimod, VRC07523LS, CAP256V2LS
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Ali AhmedDivision of Infectious Diseases and Global Public Health, School of Medicine, University of California, San Diego (UCSD), La Jolla, CA, USA.ORCID 0000-0002-8964-1853
Miranda HillDepartment of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of California, San Francisco (UCSF), San Francisco, CA, USA.
Krista L DongRagon Institute of Mass General Brigham, MIT, and Harvard, Cambridge, MA, USA.ORCID 0000-0002-2038-3518
Mzwakhe Wiseman NgcoboIntegration of TB in Education and Care for HIV/AIDS (ITEACH), Pietermaritzburg, South Africa.
Ayanda ZuluIntegration of TB in Education and Care for HIV/AIDS (ITEACH), Pietermaritzburg, South Africa.
Ntombifuthi LangaIntegration of TB in Education and Care for HIV/AIDS (ITEACH), Pietermaritzburg, South Africa.
Luyanda MaphalalaFemales Rising through Education, Support and Health (FRESH), Durban, South Africa.
Vanessa PillayFemales Rising through Education, Support and Health (FRESH), Durban, South Africa.
Maud MthembuSchool of Applied Human Sciences, Department of Social Work, University of KwaZulu-Natal (UKZN), Durban, South Africa.
Whitney TranDivision of Infectious Diseases and Global Public Health, School of Medicine, University of California, San Diego (UCSD), La Jolla, CA, USA.
Rachel LauDivision of Infectious Diseases and Global Public Health, School of Medicine, University of California, San Diego (UCSD), La Jolla, CA, USA.
Jamila K StockmanDivision of Infectious Diseases and Global Public Health, School of Medicine, University of California, San Diego (UCSD), La Jolla, CA, USA.
Thumbi Ndung'uRagon Institute of Mass General Brigham, MIT, and Harvard, Cambridge, MA, USA.
Karine DubéDivision of Infectious Diseases and Global Public Health, School of Medicine, University of California, San Diego (UCSD), La Jolla, CA, USA.ORCID 0000-0003-3458-1539

Funding

VirologyP30AI036214 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SUSAN JANET LITTLE · 1994 to 2026
$78.4M
BEAT-HIV: Delaney Collaboratory to Cure HIV-1 Infection by Combination ImmunotherapyUM1AI164570 · NIAID · WISTAR INSTITUTE · PI Luis J Montaner, James L. Riley · 2021 to 2026
$34.7M
TRAINEESHIPS IN AIDS PREVENTION STUDIEST32MH019105 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Carol Suzanne Camlin, Glenn-Milo Santos · 1989 to 2026
$15.3M
Unveiling Pathways to Ending HIV Among African American Women: Leveraging Social Networks to Enhance HIV Testing and Treatment Engagement Among MigrantsK01MH134744 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Miranda Hill · 2024 to 2026
$654k
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 AfricaR21MH132406 · NIMH · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI DUBE, KARINE · 2023 to 2023
$422k
Gates Foundation INV-033558NIAID NIH HHS P30 AI036214NIAID NIH HHS UM1 AI164570NIMH NIH HHS K01 MH134744NIMH NIH HHS L60 MH141796NIMH NIH HHS R21 MH132406NIMH NIH HHS T32 MH019105Wellcome Trust
6 · The paper itself

Abstract

IntroductionYoung women in sub-Saharan Africa bear a disproportionate HIV burden yet rarely participate in cure-related studies. Analytical treatment interruptions (ATI), used to assess sustained control off therapy, raise clinical, ethical, and psychosocial concerns.MethodsWe conducted a longitudinal qualitative study within a Phase 2A ATI trial (NCT05281510) at the FRESH site in Durban, South Africa. Nineteen women living with HIV (median age 26) completed in-depth interviews at 4 timepoints. We applied framework analysis informed by the Lazarus-Folkman stress and coping model.ResultsParticipants enrolled to contribute to science, reduce pill burden, and due to trust in the clinical team. They anticipated viral rebound, resistance, stigma, and partner transmission. Over time, many reported improved emotional well-being, using meaning-based strategies (pride in contribution) and problem-focused strategies (self-monitoring, condom negotiation). Burdens included stigma, selective disclosure, partner resistance, frequent visits, and blood draws. Benefits included increased HIV literacy, self-management, and comfort with procedures.ConclusionATI-inclusive clinical trials can be acceptable when designs include clear and ongoing education, strong confidentiality protections, mental health and peer support, partner-inclusive risk reductions, and flexible scheduling with practical supports to minimize participation burden and potential psychosocial harms.Clinical trial registrationNCT05281510.

Indexed as

Adaptation, PsychologicalAnti-HIV AgentsHIV InfectionsStress, PsychologicalAdultCoping SkillsFemaleHumansLongitudinal StudiesQualitative ResearchSouth AfricaTreatment InterruptionYoung AdultAnti-HIV AgentsHIV cure researchHIV preventionmental healthPrEPresource-limited settingswomen living with HIV

Identifiers

PMID41685863
PMCPMC12905108

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.