NCT07881575Not yet recruiting

Testing a Multi-Level Approach to Reduce Stigma for Women Living With HIV

A Hierarchical Factorial Cluster-randomized Controlled Trial to Evaluate a Multi-level Intervention to Address Stigma for Women Living With HIV.

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

This study will test two approaches to reduce HIV-related stigma and improve quality of life and viral suppression among women living with HIV in Dar es Salaam, Tanzania. Twenty health facilities will take part. One approach will help facility staff reduce stigma, while the other will use group sessions to help women manage internalized stigma. The study will include 680 women living with HIV who have missed clinic visits or attended the most recent clinic visit 14 or more days late and will follow them for 12 months. Researchers will assess quality of life and viral suppression as well as how well the approaches are delivered, what supports or limits their success, and their initial costs. A study advisory group-including women living with HIV, community partners, health care providers, and Ministry of Health representatives-will help refine the approaches, interpret the findings, and guide recommendations for wider use.

Status (registry): Not yet recruiting
Study type: Interventional
Enrollment: 680 (estimated)
First submitted: 12 Oct 2026
Start date: Mar 2027
Primary completion date: Feb 2030
Lead sponsor: RTI International
Diseases: HIV
NCT number: NCT07881575

What you commit to

Study type: Interventional
Planned participants: 680
From Mar 2027 to the primary completion date, Feb 2030
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

Severe mental health condition, acute distress, intoxication, or cognitive impairment that prevents informed consent or reliable participation. (This criterion is applied observationally by the research assistant at the point of contact and does not involve a screening instrument, a standardized assessment or a review of the client's mental health diagnoses. It is a judgement about capacity to engage with the consent conversation on that day, not a judgement about whether the woman has a mental health condition.)
Psychiatric emergency at recruitment (e.g., active suicidal intent/plan, severe agitation/psychosis) requiring urgent care.

Other

Unable to visit the facility during recruitment period
Too medically unwell at recruitment to safely complete study procedures (e.g., severe weakness, high fever, severe pain, vomiting/dehydration, shortness of breath, confusion).
Communication barrier that makes consent or data collection not feasible with available accommodations.
Refuses to provide minimum locator/tracing information needed for follow-up.

Who the study is looking for

Female, living with HIV and receiving services at one of the 20 selected HCF/CTCs
Age 18 years old and above
Evidence of care engagement challenge, defined as either:
Missed a scheduled clinic visit in the past 12 months, or
Attended the most recent clinic visit 14 or more days late
Routinely receiving services at the HCF where recruited
Not anticipating changing HCF in the next 12 months
Willing to provide whole-blood samples for viral load testing (baseline and 12 months)
Willing and able to provide informed consent.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
RTI International Study Office Coordinator of this site? Confirm its status	Dar es Salaam	Tanzania	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.