Trial Outcomes & Findings for Developing and Assessing a Male Engagement Intervention in Option B+ in Malawi (NCT NCT03477279)

Results Overview

HIV-positive male partners who presented at 12 months with a viral load \<1000 copies/mL

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1116 participants

Primary outcome timeframe

12 months

Results posted on

2021-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Individual (HIV+ Women) HIV-infected pregnant women enrolled in the individual arm of the study will receive Standard of Care Option B+ procedures.	Couple (HIV+ Women) These women will receive 1) support to recruit their male partners, 2) enhanced couple counseling and testing, and 3) support for male partner engagement in care.	Male Partners of Women in Individual These men will have access to standard of care procedures.	Male Partners of Women in Couple These men will receive 1) support with recruitment, 2) enhanced couple counseling and testing, and 3) support for engagement in care.	Control Population (HIV- Women) HIV-negative pregnant women will be invited to participate in a cross-sectional study. No intervention will be provided and no follow-up will be conducted.
Overall Study STARTED	250	250	98	168	350
Overall Study COMPLETED	203	202	98	136	349
Overall Study NOT COMPLETED	47	48	0	32	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Individual (HIV+ Women) n=246 Participants HIV-positive pregnant women enrolled in the Individual arm will receive Standard of Care Option B+ procedures.	Couple (HIV+ Women) n=249 Participants HIV-positive pregnant women enrolled in the Couple arm will receive 1) support to recruit their male partners, 2) enhanced couple counseling and testing, and 3) support for male partner engagement in care.	Male Partners of Women in Individual n=98 Participants These men will have access to standard of care procedures.	Male Partners of Women in Couple n=167 Participants These men will receive 1) support with recruitment, 2) enhanced couple counseling and testing, and 3) support for engagement in care.	Control Population (HIV- Women) n=349 Participants HIV-negative pregnant women will be invited to participate in a cross-sectional study. No intervention will be provided and no follow-up will be conducted.	Total n=1109 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=246 Participants	11 Participants n=249 Participants	1 Participants n=98 Participants	0 Participants n=167 Participants	37 Participants n=349 Participants	64 Participants n=1109 Participants
Age, Categorical Between 18 and 65 years	231 Participants n=246 Participants	238 Participants n=249 Participants	97 Participants n=98 Participants	167 Participants n=167 Participants	312 Participants n=349 Participants	1045 Participants n=1109 Participants
Age, Categorical >=65 years	0 Participants n=246 Participants	0 Participants n=249 Participants	0 Participants n=98 Participants	0 Participants n=167 Participants	0 Participants n=349 Participants	0 Participants n=1109 Participants
Sex: Female, Male Female	246 Participants n=246 Participants	249 Participants n=249 Participants	0 Participants n=98 Participants	0 Participants n=167 Participants	349 Participants n=349 Participants	844 Participants n=1109 Participants
Sex: Female, Male Male	0 Participants n=246 Participants	0 Participants n=249 Participants	98 Participants n=98 Participants	167 Participants n=167 Participants	0 Participants n=349 Participants	265 Participants n=1109 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Malawi	246 Participants n=246 Participants	249 Participants n=249 Participants	98 Participants n=98 Participants	167 Participants n=167 Participants	349 Participants n=349 Participants	1109 Participants n=1109 Participants

PRIMARY outcome

Timeframe: 12 months

Population: This is an HIV-positive female only outcome. 134 HIV-positive women did not present for the 12 month study visit

Women who presented at 12 months and reported taking at least one dose of ART in the last seven days

Outcome measures

Outcome measures
Measure	Individual (HIV+ Women) n=181 Participants HIV-positive pregnant women enrolled in the Individual arm will receive Standard of Care Option B+ procedures.	Couple (HIV+ Women) n=185 Participants HIV-positive pregnant women enrolled in the Couple arm will receive 1) support to recruit their male partners, 2) enhanced couple counseling and testing, and 3) support for male partner engagement in care.
Number of Women Retained in Care	160 Participants	164 Participants

PRIMARY outcome

Timeframe: 12 months

Population: This is an HIV-positive female only outcome.138 HIV-positive women did not present for the 12 month study visit or did not provide the blood sample required for viral load ascertainment

Women who presented at 12 months with a viral load \<1000 copies/mL

Outcome measures

Outcome measures
Measure	Individual (HIV+ Women) n=178 Participants HIV-positive pregnant women enrolled in the Individual arm will receive Standard of Care Option B+ procedures.	Couple (HIV+ Women) n=184 Participants HIV-positive pregnant women enrolled in the Couple arm will receive 1) support to recruit their male partners, 2) enhanced couple counseling and testing, and 3) support for male partner engagement in care.
Number of Women With Viral Suppression	145 Participants	162 Participants

PRIMARY outcome

Timeframe: 12 months

Population: This is a male only outcome. 141 men did not present at 12 months, or refused HIV testing at 12 months, or tested HIV-negative/indeterminate at 12 months

HIV-positive male partners who presented at 12 months and reported knowing they were HIV-positive prior to receiving the results of the HIV test conducted at the 12 month study visit

Outcome measures

Outcome measures
Measure	Individual (HIV+ Women) n=53 Participants HIV-positive pregnant women enrolled in the Individual arm will receive Standard of Care Option B+ procedures.	Couple (HIV+ Women) n=72 Participants HIV-positive pregnant women enrolled in the Couple arm will receive 1) support to recruit their male partners, 2) enhanced couple counseling and testing, and 3) support for male partner engagement in care.
Number of HIV-positive Male Partners Aware of Their HIV-positive Status	44 Participants	67 Participants

PRIMARY outcome

Timeframe: 12 months

Population: This is a male only outcome. 142 men did not present at 12 months, or refused HIV testing at 12 months, or tested HIV-negative/indeterminate at 12 months, or did not report information on ART use

HIV-positive male partners who presented at 12 months and reported taking at least one dose of ART in the last seven days

Outcome measures

Outcome measures
Measure	Individual (HIV+ Women) n=52 Participants HIV-positive pregnant women enrolled in the Individual arm will receive Standard of Care Option B+ procedures.	Couple (HIV+ Women) n=72 Participants HIV-positive pregnant women enrolled in the Couple arm will receive 1) support to recruit their male partners, 2) enhanced couple counseling and testing, and 3) support for male partner engagement in care.
Number of HIV-positive Male Partners Retained in Care	34 Participants	59 Participants

PRIMARY outcome

Timeframe: 12 months

Population: This is a male only outcome. 141 men did not present at 12 months, or refused HIV testing at 12 months, or tested HIV-negative/indeterminate at 12 months, or did not provide the blood sample required for viral load ascertainment

HIV-positive male partners who presented at 12 months with a viral load \<1000 copies/mL

Outcome measures

Outcome measures
Measure	Individual (HIV+ Women) n=53 Participants HIV-positive pregnant women enrolled in the Individual arm will receive Standard of Care Option B+ procedures.	Couple (HIV+ Women) n=72 Participants HIV-positive pregnant women enrolled in the Couple arm will receive 1) support to recruit their male partners, 2) enhanced couple counseling and testing, and 3) support for male partner engagement in care.
Number of HIV-positive Male Partners With Viral Suppression	31 Participants	53 Participants

PRIMARY outcome

Timeframe: 12 months

Population: This is a male only outcome. 162 did not present at 12 months, or refused HIV testing at 12 months, or tested HIV-positive/indeterminate at 12 months

HIV-negative men with a) consistent condom use in the last six months or b) a suppressed female partner or c) abstinence with primary partner

Outcome measures

Outcome measures
Measure	Individual (HIV+ Women) n=41 Participants HIV-positive pregnant women enrolled in the Individual arm will receive Standard of Care Option B+ procedures.	Couple (HIV+ Women) n=63 Participants HIV-positive pregnant women enrolled in the Couple arm will receive 1) support to recruit their male partners, 2) enhanced couple counseling and testing, and 3) support for male partner engagement in care.
Number of HIV-negative Men Without HIV Exposure From Their Primary Partner	39 Participants	59 Participants

SECONDARY outcome

Timeframe: 12 months

Population: This is an HIV-positive female only outcome. For 154 observations, there was no data available on infant outcomes or no live birth

HIV-positive female participants who reported a live birth and uptake of early infant diagnosis

Outcome measures

Outcome measures
Measure	Individual (HIV+ Women) n=171 Participants HIV-positive pregnant women enrolled in the Individual arm will receive Standard of Care Option B+ procedures.	Couple (HIV+ Women) n=175 Participants HIV-positive pregnant women enrolled in the Couple arm will receive 1) support to recruit their male partners, 2) enhanced couple counseling and testing, and 3) support for male partner engagement in care.
Number of HIV-positive Female Participants Who Reported Early Infant Diagnosis	162 Participants	158 Participants

SECONDARY outcome

Timeframe: At the day of female consent

Population: This is a female only outcome. Of the 500 HIV-positive women enrolled into the study, 44 were classified as having recently acquired HIV. Data unavailable for one HIV-negative woman.

Risk factor analysis to identify predictors of recent HIV infection among pregnant women