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

Not Applicable

Completed

Conditions: HIV

Interventions: Behavioral: contract referral
Behavioral: patient referral

Registration Number: NCT02139176

Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary: In sub-Saharan Africa, engaging men in HIV prevention, care, and treatment has proven challenging. Along all steps of the HIV care-seeking cascade, men exhibit worse care-seeking behaviors than women. They are less likely to be tested for HIV, initiate combination antiretroviral therapy (cART), and be retained in cART care. Additionally, men rarely engage in the care of their female sex partners, even though couple care-seeking is associated with marked improvements in condom use within HIV-discordant couples. Option B+, Malawi's program for providing immediate, lifelong combination antiretroviral therapy (cART) to all HIV-infected pregnant women at the time of diagnosis, is an important entry-point for involving male partners in care.

This is a pilot randomized controlled trial (N=200 women) comparing two strategies of male partner involvement within the Option B+ program. In both arms (patient referral and contract referral) women will be encouraged to invite their male partners to accompany them to the clinic for couple HIV counseling and testing. In the contract referral arm, if the couple does not present within one week, the male partner will receive a home visit encouraging them to present to the clinic. We will compare the two arms for 1) uptake of couple HIV counseling and testing (cHCT), 2) uptake of cART for women, and 3) linkage to care for HIV-infected men. Results are expected to inform a larger trial and ultimately improve care-seeking in Malawi's HIV program.

Objective 1: Determine acceptability of male partner recruitment for cHTC within an Option B+ context. We will assess acceptability of eligible females to participate in this pilot RCT and reasons for non-participation.

Objective 2: Assess whether study arm (patient referral versus contract referral) is associated with cHTC uptake. We will conduct a pilot randomized controlled trial (RCT) of male partner recruitment. This study will contain two arms: patient referral and contract referral for uptake of cHTC (primary outcome).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

Inclusion Criteria

18 years old or 16-17 years old and married
- Pregnant
- Received a positive HIV-test within the last day
- Will be in Lilongwe for the next month
- Able and willing to give locator information for >1 male partner in the Bwaila District Hospital catchment area (either a mobile number, a physical address, or both)

Exclusion Criteria

Enrolled/enrolling in the PROMISE study
Initially Presenting with a male sex partner

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
contract referral	patient referral	Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.
Patient referral	patient referral	Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information
contract referral	contract referral	Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.

Primary Outcome Measures

Name	Time	Method
Number of Women Who Came With Their Partners and Received Couple Counseling and Testing	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.

Secondary Outcome Measures

Name	Time	Method
Female First Option B+ Follow-up Visit	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.
Male Linkage to Care	one month from male presentation to the clinic	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.