Trial Outcomes & Findings for Assessing Strategies for Increasing Male Involvement in Malawi's Antenatal Program (NCT NCT02139176)

Results Overview

Based on whether the female partner brings her male partner to the antenatal clinic for couple HIV counseling and testing (as recorded on study case report forms) as the primary measure of uptake. We will compare time to couple HIV counseling and testing between groups using the Kaplan Meier method and a log rank test.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

200 participants

Primary outcome timeframe

three months

Results posted on

2017-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Patient Referral Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information patient referral: A patient agrees to recruit their partner using the invitation.	Contract Referral Same as control. However, if the male partner does not present, a community worker will trace the partner in the community. contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community. patient referral: A patient agrees to recruit their partner using the invitation.
Overall Study STARTED	100	100
Overall Study COMPLETED	100	100
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessing Strategies for Increasing Male Involvement in Malawi's Antenatal Program

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patient Referral n=100 Participants Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information patient referral: A patient agrees to recruit their partner using the invitation.	Contract Referral n=100 Participants Same as control. However, if the male partner does not present, a community worker will trace the partner in the community. contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community. patient referral: A patient agrees to recruit their partner using the invitation.	Total n=200 Participants Total of all reporting groups
Age, Continuous	26.5 years STANDARD_DEVIATION 0.49 • n=5 Participants	26.6 years STANDARD_DEVIATION 0.50 • n=7 Participants	26.6 years STANDARD_DEVIATION 0.35 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: three months

Based on whether the female partner brings her male partner to the antenatal clinic for couple HIV counseling and testing (as recorded on study case report forms) as the primary measure of uptake. We will compare time to couple HIV counseling and testing between groups using the Kaplan Meier method and a log rank test.

Outcome measures

Outcome measures
Measure	Patient Referral n=100 Participants Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information patient referral: A patient agrees to recruit their partner using the invitation.	Contract Referral n=100 Participants Same as control. However, if the male partner does not present, a community worker will trace the partner in the community. contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.
Number of Women Who Came With Their Partners and Received Couple Counseling and Testing	52 Female participants receiving CHTC	70 Female participants receiving CHTC

SECONDARY outcome

Timeframe: three months

It will be assessed whether the female participants return for their first Option B+ visit (using the clinic's routine Option B+ records). The number retained will be compared.

Outcome measures

Outcome measures
Measure	Patient Referral n=100 Participants Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information patient referral: A patient agrees to recruit their partner using the invitation.	Contract Referral n=100 Participants Same as control. However, if the male partner does not present, a community worker will trace the partner in the community. contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.
Female First Option B+ Follow-up Visit	83 participants	91 participants

SECONDARY outcome

Timeframe: one month from male presentation to the clinic

Population: These are only the HIV-infected men who participated in the study who were HIV-infected and not already engaged in care. That is why it is only a subset of the larger population.

It will be assessed whether newly diagnosed HIV-infected male partners are linked to care within one month of learning their HIV positive result with their partner. This will be assessed from abstraction of routine clinic records at Martin Preuss Center.

Outcome measures

Outcome measures
Measure	Patient Referral n=26 Participants Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information patient referral: A patient agrees to recruit their partner using the invitation.	Contract Referral n=33 Participants Same as control. However, if the male partner does not present, a community worker will trace the partner in the community. contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.
Male Linkage to Care	5 partners linked to care	15 partners linked to care

Adverse Events

Patient Referral

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Contract Referral

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Patient Referral n=100 participants at risk Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information patient referral: A patient agrees to recruit their partner using the invitation.	Contract Referral n=100 participants at risk Same as control. However, if the male partner does not present, a community worker will trace the partner in the community. contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.
Social circumstances social disruptions reported by women	0.00% 0/100	3.0% 3/100 • Number of events 3
Social circumstances social disruption reported by men	0.00% 0/100	1.0% 1/100 • Number of events 1

Additional Information

Nora Rosenberg, PhD

UNC Chapel Hill/UNC Project Lilongwe

Phone: +265 (0)99 109 0676

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place