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

NCT03271307 | Completed Results FDA Device

• 1 other identifier: 17-000109
• Study Type: interventional
• Target: 6,369
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

self-test; testing; cost-effectiveness

Outcome Measures

Primary Outcomes (2)

• Aim 1: Proportion of Adult OPD Clients Tested for HIV

  Same day HIV testing among OPD clients, measured by self-reports from OPD clients

  1 day

• Aim 2: Proportion of Sexual Partners Tested for HIV

  HIV testing among sexual partners of HIV-positive clients within 4-weeks of study enrollment, measured by secondary reports from HIV-positive clients

  4-weeks

Secondary Outcomes (9)

• Aim 1: HIV-positivity Rate

  Same 1 day as enrollment (measuring HIV testing before clients leave the OPD clinic that day)

• Aim 1: ART Initiation Among OPD Clients Tested HIV-positive

  3 months

• Aim 1: Presence of Non-serious Adverse Events

  as enrollment (measuring adverse events that occurred at the OPD clinic that 1 day)

• Aim 1: Cost Per Person Initiated ART

  3 months

• Aim 2: HIV-positivity Rates Among Sexual Partners Tested for HIV

  4-weeks

Study Arms (5)

AIm 1: Standard of care

NO INTERVENTION

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

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.

Behavioral: Optimized PITC

Aim 1: Facility HIVST

EXPERIMENTAL

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

Diagnostic Test: Facility HIVST

Aim 2: Standard of care

NO INTERVENTION

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

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).

Diagnostic Test: Index HIVST

Interventions

Optimized PITC BEHAVIORAL

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.

Also known as: Optimized standard of care

Aim 1: Optimized standard of care

Facility HIVST DIAGNOSTIC_TEST

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.

Aim 1: Facility HIVST

Index HIVST DIAGNOSTIC_TEST

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.

Aim 2: Index HIVST

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Partners in Hope, Inc.: collaborator
• United States Agency for International Development (USAID): collaborator
• Right to Care: collaborator
• Ministry of Health, Malawi: collaborator

Study Sites (1)

Partners in Hope

Lilongwe, Malawi

Location

Related Publications (4)

• Dovel K, Balakasi K, Phiri K, Shaba F, Offorjebe OA, Gupta SK, Wong V, Lungu E, Nichols BE, Masina T, Worku A, Hoffman R, Nyirenda M. Effect of index HIV self-testing for sexual partners of clients enrolled in antiretroviral therapy (ART) programs in Malawi: A randomized controlled trial. PLoS Med. 2023 Aug 4;20(8):e1004270. doi: 10.1371/journal.pmed.1004270. eCollection 2023 Aug.

  PMID: 37540649 DERIVED

• Mphande M, Campbell P, Hoffman RM, Phiri K, Nyirenda M, Gupta SK, Wong V, Dovel K. Barriers and facilitators to facility HIV self-testing in outpatient settings in Malawi: a qualitative study. BMC Public Health. 2021 Dec 2;21(1):2200. doi: 10.1186/s12889-021-12213-6.

  PMID: 34856958 DERIVED

• Dovel K, Shaba F, Offorjebe OA, Balakasi K, Nyirenda M, Phiri K, Gupta SK, Wong V, Tseng CH, Nichols BE, Cele R, Lungu E, Masina T, Coates TJ, Hoffman RM. Effect of facility-based HIV self-testing on uptake of testing among outpatients in Malawi: a cluster-randomised trial. Lancet Glob Health. 2020 Feb;8(2):e276-e287. doi: 10.1016/S2214-109X(19)30534-0.

  PMID: 31981557 DERIVED

• Dovel K, Shaba F, Nyirenda M, Offorjebe OA, Balakasi K, Phiri K, Nichols B, Tseng CH, Bardon A, Ngona K, Hoffman R. Evaluating the integration of HIV self-testing into low-resource health systems: study protocol for a cluster-randomized control trial from EQUIP Innovations. Trials. 2018 Sep 17;19(1):498. doi: 10.1186/s13063-018-2878-y.

  PMID: 30223874 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

Aim 2 data rely on secondary reports from ART clients regarding HIV testing and test results for their sexual partner. Secondary reports may be bias, however, are findings are similar to other HIVST studies.

Results Point of Contact

• Title: Dr. Kathryn Dovel
• Organization: University of California Los Angeles

KDovel@mednet.ucla.edu

7143303416

Study Officials

• Kathryn Dovel, PhD, MPH

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Assistant Professor

Model Details: The study will include two arms and methodology: (Aim 1) A cluster-randomized trial comparing HIV testing strategies for OPD clients, clustered by health facility; and (Aim 2) A individual-randomized trial comparing HIV testing strategies for partners of HIV-positive clients.

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 5, 2017
• Study Start: September 25, 2017
• Primary Completion: June 13, 2018
• Study Completion: January 25, 2019
• Last Updated: December 2, 2020
• Results First Posted: December 2, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)