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

NCT05074251 | Completed Results

• 1 other identifier: BRHIVSTSA1
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV self testing; HIV self screening; South Africa

Outcome Measures

Primary Outcomes (1)

• Partner HIV Testing

  proportion of index partners who report testing

  3 months

Secondary Outcomes (3)

• Positivity

  3 months

• ART Initiation

  3 months

• Viral Suppression

  3 months

Study Arms (2)

HIV self testing

EXPERIMENTAL

HIV+ women will receive HIV self-tests (2) to bring home to her partner to offer for testing

Diagnostic Test: HIV self test; Behavioral: Counseling and referral for partner testing

Standard of care

ACTIVE COMPARATOR

In the standard of care arm, women will receive standard of care partner referrals for HIV testing, including counselling about disclosure and referral for her partner(s) to return to the facility for testing.

Behavioral: Counseling and referral for partner testing

Interventions

HIV self test DIAGNOSTIC_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).

Also known as: counseling on partner testing and HIV self testing

HIV self testing

Counseling and referral for partner testing BEHAVIORAL

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

HIV self testing; Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Emory University: collaborator
• BroadReach Healthcare: collaborator
• United States Agency for International Development (USAID): collaborator
• Mpumalanga Department of Health: collaborator

Study Sites (1)

Department of Health Clinics

Nkangala, Mpumalanga, South Africa

Location

Related Publications (1)

• Joseph Davey DL, Wall KM, Naidoo N, Naidoo D, Xaba G, Serao C, Malone T, Dovel K. HIV testing and linkage to ART following secondary distribution of HIV self-test kits to male partners of women living with HIV: a pilot randomized control trial in Mpumalanga, South Africa. J Int AIDS Soc. 2022 Jun;25(6):e25937. doi: 10.1002/jia2.25937.

  PMID: 35690880 DERIVED

MeSH Terms

Conditions

HIV Infections; HIV Seropositivity

Interventions

Counseling; Referral and Consultation

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

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Professional Practice; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Dr. Dvora Joseph Davey
• Organization: UCLA

dvoradavey@ucla.edu

310-701-1526

Study Officials

• Kristin Wall, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

• Kathryn Dovel, PhD

  University of California, Los Angeles

  STUDY DIRECTOR

• Dhirisha Naidoo

  BroadReach Healthcare

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 12, 2021
• Study Start: April 20, 2021
• Primary Completion: August 6, 2021
• Study Completion: August 24, 2021
• Last Updated: December 8, 2023
• Results First Posted: December 8, 2023

Record last verified: 2023-03

Locations

ZA (1)