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

NCT ID: NCT05074251

Last Updated: 2023-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-20
• Study Completion Date: 2021-08-24

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.

Detailed Description

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.

We will partner with BroadReach Healthcare, a PEPFAR partner in South Africa, to pilot test an innovative index partner HIVSS strategy in one urban and one rural public health clinic in the Nkangala district of Mpumalanga Province to evaluate acceptability, barriers, and preliminary 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 HIVSSs with HIVSS 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 SA national guidelines). We will evaluate the following aims:

1. Conduct a mixed-methods survey with N=180 HIV+ women to assess perceived acceptability and barriers (including perceived safety, IPV) to secondary HIVSS distribution by women to male partners.

2. Test the feasibility and preliminary efficacy of secondary HIVSS distribution through a 1:1 randomized control trial in n=180 HIV+ women to assess, comparing standard of care to intervention arm:

1. % of index women who self-report that they gave the HIVSS or standard of care referral for testing to their male partner

2. % of male partners who either screened or tested for HIV assessed at 3 months after randomization (primary outcome)

i. Measured via options of: index or partner self-report, SMS/WhatsApp of a picture of the used HIVSS sent by partner or index, return of a used self-test to the facility by either the index or partner, and/or partner coming into facility for with an invitation for confirmatory testing or SOC counseling referral c. % of male partners with a positive HIV screening/test result d. % of newly diagnosed male partners who initiate ART within 3 months of diagnosis e. % of those on ART with viral suppression after 6 months on ART (index and partners)

3. In the intervention arm, we will assess acceptability and barriers (including safety/IPV) related to HIVSS distribution or use via surveys with all intervention participants who return for the study endline survey and a convenience samples of n=20 male partners (n=10 men who used HIVSS and n=10 men who did not use HIVSS)

Conditions

HIV Infections; ART; HIV Seropositivity

Keywords

HIV self testing; HIV self screening; South Africa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HIV self testing

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

Group Type: EXPERIMENTAL

HIV self test

Intervention Type: 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).

Counseling and referral for partner testing

Intervention Type: BEHAVIORAL

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

Standard of care

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.

Group Type: ACTIVE_COMPARATOR

Counseling and referral for partner testing

Intervention Type: BEHAVIORAL

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

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

Counseling and referral for partner testing

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

Intervention Type: BEHAVIORAL

Other Intervention Names

counseling on partner testing and HIV self testing

Eligibility Criteria

Inclusion Criteria

1. Adult female 18+ years old

2. confirmed HIV-positive or on ART

3. confirmed to currently have a male partner and are sexually active

4. male partner is of HIV- or unknown status

5. confirmed to have a cell phone that can read and respond to SMS/WhatsApp messages

6. 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

BroadReach Healthcare

INDUSTRY

Sponsor Role: collaborator

United States Agency for International Development (USAID)

FED

Sponsor Role: collaborator

Mpumalanga Department of Health

OTHER_GOV

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Dvora Joseph Davey, PhD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin Wall, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Kathryn Dovel, PhD

Role: STUDY_DIRECTOR

University of California, Los Angeles

Dhirisha Naidoo

Role: STUDY_DIRECTOR

BroadReach Healthcare

Locations

Department of Health Clinics

Nkangala, Mpumalanga, South Africa

Countries

South Africa

References

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.

Reference Type: DERIVED

PMID: 35690880 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

BRHIVSTSA1

Identifier Type: -

Identifier Source: org_study_id