Clinical trial NCT05074251: Evaluation of Secondary Distribution of HIV Self-screening Tests by Women With HIV
Official title: Pilot Study of Secondary Distribution of HIV Self-screening Tests by Women With HIV: An Innovative Strategy to Improve Testing, Identification, and Linkage to Treatment of Men in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
ART
HIV Seropositivity
Keywords: HIV self testing
HIV self screening
South Africa
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Emory University
name: BroadReach Healthcare
name: United States Agency for International Development (USAID)
name: Mpumalanga Department of Health
First posted: 2021-10-12
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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)

Exclusion Criteria:

Failure to meet all of inclusion criteria

Primary outcomes:
measure: Partner HIV Testing
timeFrame: 3 months
Secondary outcomes:
measure: Positivity
timeFrame: 3 months
measure: ART Initiation
timeFrame: 3 months
measure: Viral Suppression
timeFrame: 3 months
Other outcomes:
Locations:
city: Nkangala
country: South Africa
facility: Department of Health Clinics
state: Mpumalanga
Study officials:
affiliation: Emory University
name: Kristin Wall, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Kathryn Dovel, PhD
role: STUDY_DIRECTOR
affiliation: BroadReach Healthcare
name: Dhirisha Naidoo
role: STUDY_DIRECTOR
References:
citation: 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.