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

NCT ID: NCT02139176

Last Updated: 2017-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-01-31

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).

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Patient referral

Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information

Group Type: ACTIVE_COMPARATOR

patient referral

Intervention Type: BEHAVIORAL

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.

Group Type: EXPERIMENTAL

contract referral

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

A patient agrees to recruit their partner using the invitation.

Interventions

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.

Intervention Type: BEHAVIORAL

patient referral

A patient agrees to recruit their partner using the invitation.

Intervention Type: BEHAVIORAL

Other Intervention Names

partner notification; contract partner notification; invitation plus tracing; passive referral; patient notification; invitation only

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nora E Rosenberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Mina Hosseinipour, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Bwaila District Hospital Antenatal Unit

Lilongwe, Central District, Malawi

Countries

Malawi

References

Rosenberg NE, Mtande TK, Saidi F, Stanley C, Jere E, Paile L, Kumwenda K, Mofolo I, Ng'ambi W, Miller WC, Hoffman I, Hosseinipour M. Recruiting male partners for couple HIV testing and counselling in Malawi's option B+ programme: an unblinded randomised controlled trial. Lancet HIV. 2015 Nov;2(11):e483-91. doi: 10.1016/S2352-3018(15)00182-4. Epub 2015 Oct 22.

Reference Type: DERIVED

PMID: 26520928 (View on PubMed)

Other Identifiers

13-3707

Identifier Type: -

Identifier Source: org_study_id