CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 180 enrolled
Drug / intervention
HIV self test +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05074251
NCT05074251N/ACompleted

Pilot Study of Secondary Distribution of HIV Self-screening Tests by Women With HIV: An Innovative Strategy to Improve Testing, Identification, and Linkage to Treatment of Men in South Africa

University of California, Los Angeles·interventional·Posted Oct 12, 2021·Updated Dec 8, 2023

In Brief

A clinical study evaluating HIV self test and Counseling and referral for partner testing for HIV Infections and 2 related conditions. Completed, enrolled 180 participants across 1 site.

Detailed Summary

Many South African men do not visit clinics or get tested due to multiple real and perceived barriers. Nkangala District has significant gaps to identifying PLHIV who are not on ART, reaching their ART targets, especially in adult men. Over 65% of PLHIV not on ART are men, which is a gap of over 39,000 men living with HIV needing to be tested and initiated on ART. * To improve case finding among men in Nkangala we will evaluate how best to reach partners of PLHIV (newly diagnosed or on ART) with index testing by using HIV self-screening (HIVSS) and linkage to ART start. * Secondary distribution of HIV self-screening kits (HIVSS), whereby clients bring HIVSS kits to their partners, addresses barriers by enabling partners to screen themselves at their convenience and in the privacy of their homes. Study Objectives: BroadReach in collaboration with UCLA, UCT and Nkangala DOH will pilot test an innovative index partner HIVSS strategy in one urban and one rural clinic to evaluate acceptability, barriers, and efficacy of secondary HIVSS distribution in a randomized control trial enrolling women newly diagnosed with HIV or on ART. * In the intervention arm, women will receive counselling on how to use HIVSS, how to encourage their male partner to screen, and 2 oraquick HIVSS with instructions and invitation to return for confirmatory testing. * In the standard of care arm, index women will receive counselling on the importance of disclosure to their family and partner(s) and referral for HIV testing (per South African national guidelines). Study design: Randomized control trial of n=180 WLHIV (90 in each arm) in four facilities (urban and rural) in the Nkangala district ensure that the results are generalizable.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Africa

Timeline

N/ACompletedFinished
20222023202420252026
First PostedOct 12, 2021
Enrollment StartApr 20, 2021
Primary CompletionAug 6, 2021
Study CompletionAug 24, 2021
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.7 years ago

Interventions

HIV self testother

For women allocated to the intervention arm, the participant will be given HIV self testing and counseling on their use \& importance of partner testing, to take home to their partner(s).

Counseling and referral for partner testingbehavioral

Counseling and refer participant's partner for facility based HIV testing