Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners

Summary

This study comprises two trials to evaluate the feasibility and cost-effectiveness of HIV self-testing strategies compared to standard of care among clients in outpatient departments (OPD; Aim 1) and the sexual partners of HIV-positive clients (index testing; Aim 2).

Aim 1 will be a cluster-randomized trial in 15 clusters (high-burden health facilities) in Malawi. We will enroll 6,000 adult OPD clients (15 years or older) to test the feasibility and cost-effectiveness of facility-based HIV self-testing (HIVST) for OPD clients.

Aim 2 will be an individually-randomized trial in 3 high-burden health facilities in Malawi. We will enroll 500 adult HIV-positive clients (15 years or older) to test the feasibility and cost-effectiveness of index HIVST among partners of HIV-positive clients.

Conditions

• HIV Infections

Interventions

BEHAVIORAL

Optimized PITC

Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation.

DIAGNOSTIC_TEST

Facility HIVST

HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted.

DIAGNOSTIC_TEST

Index HIVST

HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.

Sponsors & Collaborators

• Partners in Hope, Inc.

  collaborator INDUSTRY

• United States Agency for International Development (USAID)

  collaborator FED

• Right to Care

  collaborator OTHER

• Ministry of Health, Malawi

  collaborator OTHER_GOV

• University of California, Los Angeles

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-09-25

Primary Completion

2018-06-13

Completion

2019-01-25

FDA Device

Yes

Countries

• Malawi

Study Locations