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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05074251
Acronym
HIVSSSA
Enrollment
180
Registered
2021-10-12
Start date
2021-04-20
Completion date
2021-08-24
Last updated
2023-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ART, HIV Infections, HIV Seropositivity

Keywords

HIV self testing, HIV self screening, South Africa

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)

Interventions

DIAGNOSTIC_TESTHIV 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).

BEHAVIORALCounseling and referral for partner testing

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

Sponsors

Emory University
CollaboratorOTHER
BroadReach Healthcare
CollaboratorINDUSTRY
United States Agency for International Development (USAID)
CollaboratorFED
Mpumalanga Department of Health
CollaboratorOTHER_GOV
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Partner HIV Testing3 monthsproportion of index partners who report testing

Secondary

MeasureTime frameDescription
Positivity3 monthsProportion of male partners tested who test HIV+
ART Initiation3 monthsProportion of male partners tested who initiate antiretroviral therapy (ART)
Viral Suppression3 monthsProportion of male partners and index partners who achieve viral suppression

Countries

South Africa

Participant flow

Participants by arm

ArmCount
HIV Self Testing
HIV+ women will receive HIV self-tests (2) to bring home to her partner to offer for testing 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). Counseling and referral for partner testing: Counseling and refer participant's partner for facility based HIV testing
86
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. Counseling and referral for partner testing: Counseling and refer participant's partner for facility based HIV testing
94
Total180

Baseline characteristics

CharacteristicStandard of CareTotalHIV Self Testing
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
94 Participants180 Participants86 Participants
Age, Continuous36 years
STANDARD_DEVIATION 8.5
35 years
STANDARD_DEVIATION 8.5
34 years
STANDARD_DEVIATION 8.6
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
94 Participants180 Participants86 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
South Africa
94 Participants180 Participants86 Participants
Sex: Female, Male
Female
94 Participants180 Participants86 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 860 / 91
other
Total, other adverse events
0 / 860 / 91
serious
Total, serious adverse events
0 / 860 / 91

Outcome results

Primary

Partner HIV Testing

proportion of index partners who report testing

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
HIV Self TestingPartner HIV Testing66 Participants
Standard of CarePartner HIV Testing50 Participants
p-value: <0.0595% CI: [1.14, 1.75]Regression, Logistic
Secondary

ART Initiation

Proportion of male partners tested who initiate antiretroviral therapy (ART)

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
HIV Self TestingART Initiation6 Participants
Standard of CareART Initiation6 Participants
Secondary

Positivity

Proportion of male partners tested who test HIV+

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
HIV Self TestingPositivity9 Participants
Standard of CarePositivity6 Participants
Secondary

Viral Suppression

Proportion of male partners and index partners who achieve viral suppression

Time frame: 3 months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026