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

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.

Conditions

• HIV Infections
• ART
• HIV Seropositivity

Interventions

DIAGNOSTIC_TEST

HIV self test

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).

BEHAVIORAL

Counseling and referral for partner testing

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

Sponsors & Collaborators

• Emory University

  collaborator OTHER

• BroadReach Healthcare

  collaborator INDUSTRY

• United States Agency for International Development (USAID)

  collaborator FED

• Mpumalanga Department of Health

  collaborator OTHER_GOV

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• Kristin Wall, PhD · Emory University

• Kathryn Dovel, PhD · University of California, Los Angeles

• Dhirisha Naidoo · BroadReach Healthcare

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-04-20

Primary Completion

2021-08-06

Completion

2021-08-24

Countries

• South Africa