Trial Outcomes & Findings for Evaluation of Secondary Distribution of HIV Self-screening Tests by Women With HIV (NCT NCT05074251)

NCT ID: NCT05074251

Last Updated: 2023-12-08

Results Overview

proportion of index partners who report testing

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 180 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2023-12-08

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	86	94
Overall Study COMPLETED	85	91
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	HIV Self Testing n=86 Participants 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	Standard of Care n=94 Participants 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	Total n=180 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	86 Participants n=93 Participants	94 Participants n=4 Participants	180 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	34 years STANDARD_DEVIATION 8.6 • n=93 Participants	36 years STANDARD_DEVIATION 8.5 • n=4 Participants	35 years STANDARD_DEVIATION 8.5 • n=27 Participants
Sex: Female, Male Female	86 Participants n=93 Participants	94 Participants n=4 Participants	180 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	86 Participants n=93 Participants	94 Participants n=4 Participants	180 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment South Africa	86 Participants n=93 Participants	94 Participants n=4 Participants	180 Participants n=27 Participants

PRIMARY outcome

Timeframe: 3 months

proportion of index partners who report testing

Outcome measures

Measure	HIV Self Testing n=86 Participants 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	Standard of Care n=91 Participants 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
Partner HIV Testing	66 Participants	50 Participants

SECONDARY outcome

Timeframe: 3 months

Proportion of male partners tested who test HIV+

Outcome measures

Measure	HIV Self Testing n=85 Participants 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	Standard of Care n=91 Participants 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
Positivity	9 Participants	6 Participants

SECONDARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	HIV Self Testing n=9 Participants 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	Standard of Care n=6 Participants 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
ART Initiation	6 Participants	6 Participants

SECONDARY outcome

Timeframe: 3 months

Proportion of male partners and index partners who achieve viral suppression

Outcome measures

Outcome data not reported

Adverse Events

HIV Self Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dvora Joseph Davey

UCLA

Phone: 310-701-1526

Email: dvoradavey@ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place