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N/A Completed N=180 Randomized Treatment

Evaluation of Secondary Distribution of HIV Self-screening Tests by Women With HIV

HIV Infections · ART · HIV Seropositivity
Source: ClinicalTrials.gov NCT05074251 ↗
Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Partner HIV Testing — 66; 50 Participants — p=<0.05

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Partner HIV Testing
66; 50 <0.05 sig
SECONDARY
Positivity
9; 6
SECONDARY
ART Initiation
6; 6
SECONDARY
Viral Suppression

Eligibility Criteria

Inclusion Criteria

  • Adult female 18+ years old
  • confirmed HIV-positive or on ART
  • confirmed to currently have a male partner and are sexually active
  • male partner is of HIV- or unknown status
  • confirmed to have a cell phone that can read and respond to SMS/WhatsApp messages
  • confirmed to be able to consent to study participation (no language constraints or psychological issues that would make it difficult to consent to participate in the study)

Exclusion Criteria

Failure to meet all of inclusion criteria

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05074251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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