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

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: HIV Infections

Treatments: Diagnostic Test: Facility HIVST; Diagnostic Test: Index HIVST; Behavioral: Optimized PITC

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03271307

17-000109

Details and patient eligibility

About

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.

Full description

The study includes two unblinded trials to evaluate the feasibility and cost-effectiveness of HIVST strategies among adults in Malawi.

Aim 1 will test the feasibility and cost-effectiveness of facility-based HIVST in OPD sites in Malawi. It will be an unblinded cluster-randomized trial and include three arms: 1) standard of care for provider-initiated testing and counseling (PITC); (2) optimized standard of care for PITC; and (3) facility-based HIVST while clients wait for routine OPD services. The standard of care arm will receive no intervention. The optimized standard of care arm will receive training and support for implementing the Malawi guidelines for PITC and morning testing. OPD clients in the facility HIVST arm will receive a HIVST demonstration and distribution, followed by uses of HIVST and private spaces for kit interpretation before receiving routine OPD services. Participants may present their self-test results to their provider, who will refer them for confirmatory HIV testing and routine ART initiation (if positive). That same day, participants from all arms will complete a brief survey upon exiting the clinic. Survey and medical record data will be compared across arms to determine whether facility HIVST is superior in regard to number of individuals tested for HIV, cost-effectiveness, number of HIV-positive individuals identified, and linkage rates for those who identify as HIV-positive.

Aim 2 will test the feasibility and cost-effectiveness of index HIVST for the sexual partners of HIV-positive clients. It will be an unblinded individually-randomized trial and include two arms: 1) standard of care partner referral slips for testing; and 2) HIVST. The standard of care arm will receive no intervention for partner notification and referral. HIV-positive clients in the HIVST arm will receive a HIVST demonstration and distribution, with instructions to give the HIVST kit to their sexual partner. Participants will be given one HIVST for each of their sexual partners who has an unknown HIV status or who tested HIV-negative more than six months prior (up to 3 HIVST kits distributed). Participants (index clients) will be given instructions on how their partner can complete the self-test and how to refer their partner(s) to care if they receive a positive result from the self-test. All participants (standard of care and HIVST arms) will complete a brief survey at the beginning of the intervention and a 4-week follow-up survey to assess primary and secondary outcomes. Medical chart reviews will be conducted for all partners reported to test HIV-positive in order to assess ART initiation rates. Survey and medical record data will be compared across arms to determine whether index HIVST is superior in regard to number of partners tested for HIV, cost-effectiveness, number of HIV-positive individuals identified, and linkage rates for those who identify as HIV-positive.

Enrollment: 6,369 patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 15 years or older
• Willing and able to provide informed consent
• Being seen for OPD services at the time of the study (Aim 1)
• HIV-positive (Aim 2)
• Have at least one sex partner in the catchment area with an unknown HIV status at the time of study enrollment (Aim 2)

Exclusion criteria

• Currently enrolled in the INTERVAL study
• Guardians attending clinics with OPD clients (Aim 1)
• History of intimate partner violence in the past 12 months (Aim 2)
• Fear of intimate partner violence as a consequence of participating in the study (Aim 2)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,369 participants in 5 patient groups

AIm 1: Standard of care

No Intervention group

Description:

Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for outpatients in Aim 1. PITC guidelines recommend providers inform their OPD clients about HIV testing and refer them to HIV testing services at the facility.

Aim 1: Optimized standard of care

Experimental group

Description:

Facilities assigned to the optimized standard of care arm will receive additional guidance and support from the study team to adopt the Ministry of Health National HIV Guidelines for provider-initiated testing and counseling (PITC) for Aim 1.

Treatment:

Behavioral: Optimized PITC

Aim 1: Facility HIVST

Experimental group

Description:

Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (PITC).

Treatment:

Diagnostic Test: Facility HIVST

Aim 2: Standard of care

No Intervention group

Description:

Facilities assigned to the standard of care arm will receive no intervention and will continue with Ministry of Health National HIV Guidelines for index HIV testing for sexual partners of HIV-positive clients. Partner referral slips will be given to HIV-positive clients to encourage partner testing.

Aim 2: Index HIVST

Experimental group

Description:

Facilities assigned to the HIVST arm will implement HIVST procedures in lieu of recommendations provided by the Ministry of Health National HIV Guidelines (partner referral slips).

Treatment:

Diagnostic Test: Index HIVST