Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05074251 |
| Other study ID # |
BRHIVSTSA1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 20, 2021 |
| Est. completion date |
August 24, 2021 |
Study information
| Verified date |
March 2023 |
| Source |
University of California, Los Angeles |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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)
