Trial Outcomes & Findings for HIV Self Testing of Male Partners of Women in PMTCT (NCT NCT03484533)

NCT ID: NCT03484533

Last Updated: 2025-03-27

Results Overview

Evaluate whether the secondary distribution of HIV self-tests to enrolled male partners of HIV-infected Ugandan women in PMTCT B+ increases the proportion of male partners who test for HIV

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 736 participants
• Primary outcome timeframe: Up to 12 months post-partum
• Results posted on: 2025-03-27

Participant Flow

Data provided is for the women who were enrolled and randomized to the intervention of secondary distribution of HIV self-test kits to their male partner or standard of care delivery of invitation letter to their male partner to test for HIV at the clinic and for male partners who were consented later in the study.

Participant milestones

Measure	HIV Self-test Kit HIV self-test kit: We will conduct a randomized trial to evaluate whether provision of oral HIV self-test kits to HIV-positive pregnant women overcomes their male partners' reluctance to be tested in PMTCT clinics. Pregnant women who are randomized to the HIVST arm will be trained in the use and interpretation of HIVST, and given two oral fluid-based HIVST kits to use with or give to their partners, along with information about HIV testing and prevention and care services. We will offer men confirmatory testing regardless of their HIV test result through HIVST, counseling, and if negative, PrEP and if positive, ART.	Invitation Letter-standard of Care Standard of Care: In the standard of care arm, we will give women invitation letters to deliver to their male partners to come to the ANC clinic for fast-tracked HIV testing. We will offer men counseling and if negative, PrEP and if positive, ART.	Male Partner (HIV Self-test Kit) Male partners of female participants randomized to receive the HIV self-test kit.	Male Partner (Invitation Letter) Male partners of women randomized to receive the invitation letter
Overall Study STARTED	332	168	161	75
Overall Study COMPLETED	291	146	54	25
Overall Study NOT COMPLETED	41	22	107	50

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	HIV Self-test Kit: Female n=332 Participants HIV self-test kit: We will conduct a randomized trial to evaluate whether provision of oral HIV self-test kits to HIV-positive pregnant women overcomes their male partners' reluctance to be tested in PMTCT clinics. Pregnant women who are randomized to the HIVST arm will be trained in the use and interpretation of HIVST, and given two oral fluid-based HIVST kits to use with or give to their partners, along with information about HIV testing and prevention and care services. We will offer men confirmatory testing regardless of their HIV test result through HIVST, counseling, and if negative, PrEP and if positive, ART.	Invitation Letter-standard of Care: Female n=168 Participants Standard of Care: In the standard of care arm, we will give women invitation letters to deliver to their male partners to come to the ANC clinic for fast-tracked HIV testing. We will offer men counseling and if negative, PrEP and if positive, ART.	HIV Self-test Kit: Male Partner n=161 Participants HIV self-test kit: Male partners of randomized HIV-positive pregnant women who will be given oral fluid-based HIVST kits to use, along with information about HIV testing and prevention and care services. Men were offered confirmatory testing regardless of their HIV test result through HIVST, counseling, and if negative, PrEP and if positive, ART.	Invitation Letter-standard of Care: Male Partner n=75 Participants Standard of Care: In the standard of care arm, male partners will be given invitation letters to come to the ANC clinic for fast-tracked HIV testing. We will offer men counseling and if negative, PrEP and if positive, ART.	Total n=736 Participants Total of all reporting groups
Age, Continuous	26 years n=332 Participants	27 years n=168 Participants	32 years n=161 Participants	31 years n=75 Participants	27 years n=736 Participants
Sex: Female, Male Female	332 Participants n=332 Participants	168 Participants n=168 Participants	0 Participants n=161 Participants	0 Participants n=75 Participants	500 Participants n=736 Participants
Sex: Female, Male Male	0 Participants n=332 Participants	0 Participants n=168 Participants	161 Participants n=161 Participants	75 Participants n=75 Participants	236 Participants n=736 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Uganda	332 participants n=332 Participants	168 participants n=168 Participants	161 participants n=161 Participants	75 participants n=75 Participants	736 participants n=736 Participants

PRIMARY outcome

Timeframe: Up to 12 months post-partum

Population: Overall 236 enrolled male partners tested for HIV

Evaluate whether the secondary distribution of HIV self-tests to enrolled male partners of HIV-infected Ugandan women in PMTCT B+ increases the proportion of male partners who test for HIV

Outcome measures

Measure	HIV Self-test Kit n=161 Participants HIV self-test kit: The number of enrolled men who were given a oral fluid-based HIVST kits to use by their partner, along with information about HIV testing and prevention and care services. We will offer men confirmatory testing regardless of their HIV test result through HIVST, counseling, and if negative, PrEP and if positive, ART.	Invitation Letter-standard of Care n=75 Participants Standard of Care: The number of enrolled men who received an invitation letters from their partner to come to the ANC clinic for fast-tracked HIV testing. We will offer men counseling and if negative, PrEP and if positive, ART.
Proportion of Men Who Test for HIV in the Self-test Arm to Men Who Test for HIV in the Standard of Care Arm	161 participants	75 participants

PRIMARY outcome

Timeframe: Up to 12 months post-partum

Population: There were 51 newly identified male partners living with HIV, between the two arms.

Evaluate whether the secondary distribution of HIV self-tests to male partners of HIV-infected Ugandan women in PMTCT B+ is associated with male partners uptake of ART if they test HIV-positive.

Outcome measures

Measure	HIV Self-test Kit n=38 Participants HIV self-test kit: The number of enrolled men who were given a oral fluid-based HIVST kits to use by their partner, along with information about HIV testing and prevention and care services. We will offer men confirmatory testing regardless of their HIV test result through HIVST, counseling, and if negative, PrEP and if positive, ART.	Invitation Letter-standard of Care n=13 Participants Standard of Care: The number of enrolled men who received an invitation letters from their partner to come to the ANC clinic for fast-tracked HIV testing. We will offer men counseling and if negative, PrEP and if positive, ART.
The Proportion of HIV-positive Men Who Initiate ART in the Self-test Arm to the Standard of Care Arm	33 Participants	12 Participants

PRIMARY outcome

Timeframe: Up to 12 months post-partum

Population: There were 185 male partners without HIV in the two arms.

Evaluate whether the secondary distribution of HIV self-tests to male partners of HIV-infected Ugandan women in PMTCT B+ is associated with male partners uptake of PrEP if they test HIV-negative

Outcome measures

Measure	HIV Self-test Kit n=123 Participants HIV self-test kit: The number of enrolled men who were given a oral fluid-based HIVST kits to use by their partner, along with information about HIV testing and prevention and care services. We will offer men confirmatory testing regardless of their HIV test result through HIVST, counseling, and if negative, PrEP and if positive, ART.	Invitation Letter-standard of Care n=62 Participants Standard of Care: The number of enrolled men who received an invitation letters from their partner to come to the ANC clinic for fast-tracked HIV testing. We will offer men counseling and if negative, PrEP and if positive, ART.
The Proportion of HIV-negative Men Who Initiate PrEP in the Self-test Arm to the Standard of Care Arm	72 Participants	41 Participants

SECONDARY outcome

Timeframe: Up to 12 months post-partum

Population: There were 428 women with VL available at 12 months post-partum.

Evaluate whether the secondary distribution of HIV self-tests to male partners of HIV-infected Ugandan women in PMTCT B+ is associated with effective post-partum viral suppression among HIV-infected Uganda women.

Outcome measures

Measure	HIV Self-test Kit n=284 Participants HIV self-test kit: The number of enrolled men who were given a oral fluid-based HIVST kits to use by their partner, along with information about HIV testing and prevention and care services. We will offer men confirmatory testing regardless of their HIV test result through HIVST, counseling, and if negative, PrEP and if positive, ART.	Invitation Letter-standard of Care n=144 Participants Standard of Care: The number of enrolled men who received an invitation letters from their partner to come to the ANC clinic for fast-tracked HIV testing. We will offer men counseling and if negative, PrEP and if positive, ART.
Viral Suppression at 12 Months Post-partum in HIV-infected Ugandan Women as Measured by Viral Load Testing	239 Participants	110 Participants

SECONDARY outcome

Timeframe: Up to 12 months post-partum

HIV-infected pregnant women and their male partners, experiences, perspectives and views on HIV self-testing evaluated by an inductive content analytic approach conducted through qualitative interviews. This does not permit quantification of numbers of persons who endorsed particular themes. The main themes reported were 1. Women's fear about delivering HIV self-testing kits to their partner particularly if they had not previously disclosed their HIV status to their partner. 2. Variable strategies used by women to introduce HIV self-testing to their male partners. 3. Range of male partner responses to receiving an HIV self-testing kit. 4. Women's confidence in ability to interpret HIV self-test results for their partners. 5. Women's strategies to persuade their partners to link to HIV care or HIV PrEP.

Outcome measures

Measure	HIV Self-test Kit n=29 Participants HIV self-test kit: The number of enrolled men who were given a oral fluid-based HIVST kits to use by their partner, along with information about HIV testing and prevention and care services. We will offer men confirmatory testing regardless of their HIV test result through HIVST, counseling, and if negative, PrEP and if positive, ART.	Invitation Letter-standard of Care n=30 Participants Standard of Care: The number of enrolled men who received an invitation letters from their partner to come to the ANC clinic for fast-tracked HIV testing. We will offer men counseling and if negative, PrEP and if positive, ART.
The Acceptability of HIV Self-testing Among Pregnant Women Taking Part in PMTCT B+, and Their Male Partners	29 Participants	30 Participants

Adverse Events

HIV Self-test Kit: Female

Serious events: 5 serious events

Other events: 5 other events

Deaths: 2 deaths

Invitation Letter-standard of Care: Female

Serious events: 1 serious events

Other events: 1 other events

Deaths: 2 deaths

Serious adverse events

Measure	HIV Self-test Kit: Female n=332 participants at risk HIV self-test kit: We will conduct a randomized trial to evaluate whether provision of oral HIV self-test kits to HIV-positive pregnant women overcomes their male partners' reluctance to be tested in PMTCT clinics. Pregnant women who are randomized to the HIVST arm will be trained in the use and interpretation of HIVST, and given two oral fluid-based HIVST kits to use with or give to their partners, along with information about HIV testing and prevention and care services. We will offer men confirmatory testing regardless of their HIV test result through HIVST, counseling, and if negative, PrEP and if positive, ART.	Invitation Letter-standard of Care: Female n=168 participants at risk Standard of Care: In the standard of care arm, we will give women invitation letters to deliver to their male partners to come to the ANC clinic for fast-tracked HIV testing. We will offer men counseling and if negative, PrEP and if positive, ART.
Pregnancy, puerperium and perinatal conditions Hospitalization	1.5% 5/332 • Number of events 332 • 12 months Social harms and pregnancy outcomes were recorded for the cohort, in addition to serious adverse events. We did not record death, SAEs, or Other AEs for male partners who were enrolled.	0.60% 1/168 • Number of events 168 • 12 months Social harms and pregnancy outcomes were recorded for the cohort, in addition to serious adverse events. We did not record death, SAEs, or Other AEs for male partners who were enrolled.

Other adverse events

Measure	HIV Self-test Kit: Female n=332 participants at risk HIV self-test kit: We will conduct a randomized trial to evaluate whether provision of oral HIV self-test kits to HIV-positive pregnant women overcomes their male partners' reluctance to be tested in PMTCT clinics. Pregnant women who are randomized to the HIVST arm will be trained in the use and interpretation of HIVST, and given two oral fluid-based HIVST kits to use with or give to their partners, along with information about HIV testing and prevention and care services. We will offer men confirmatory testing regardless of their HIV test result through HIVST, counseling, and if negative, PrEP and if positive, ART.	Invitation Letter-standard of Care: Female n=168 participants at risk Standard of Care: In the standard of care arm, we will give women invitation letters to deliver to their male partners to come to the ANC clinic for fast-tracked HIV testing. We will offer men counseling and if negative, PrEP and if positive, ART.
Social circumstances Social Harm	1.5% 5/332 • Number of events 5 • 12 months Social harms and pregnancy outcomes were recorded for the cohort, in addition to serious adverse events. We did not record death, SAEs, or Other AEs for male partners who were enrolled.	0.60% 1/168 • Number of events 1 • 12 months Social harms and pregnancy outcomes were recorded for the cohort, in addition to serious adverse events. We did not record death, SAEs, or Other AEs for male partners who were enrolled.

Additional Information

Andrew Mujugira

Makerere University Infectious Diseases Institute

Phone: 206 520 3800

Email: mujugira@uw.edu

Results disclosure agreements

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