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

NCT02139176 | Completed Results

• 1 other identifier: 13-3707
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

couple HIV testing and counseling; disclosure; discordant; HIV; Malawi

Outcome Measures

Primary Outcomes (1)

• Number of Women Who Came With Their Partners and Received Couple Counseling and Testing

  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.

  three months

Secondary Outcomes (2)

• Female First Option B+ Follow-up Visit

  three months

• Male Linkage to Care

  one month from male presentation to the clinic

Study Arms (2)

Patient referral

ACTIVE COMPARATOR

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

Behavioral: patient referral

contract referral

EXPERIMENTAL

Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.

Behavioral: contract referral; Behavioral: patient referral

Interventions

contract referral BEHAVIORAL

A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.

Also known as: partner notification, contract partner notification, invitation plus tracing

contract referral

patient referral BEHAVIORAL

A patient agrees to recruit their partner using the invitation.

Also known as: passive referral, patient notification, invitation only

Patient referral; contract referral

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

Bwaila District Hospital Antenatal Unit

Lilongwe, Central District, Malawi

Location

Related Publications (1)

• 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.

  PMID: 26520928 DERIVED

MeSH Terms

Interventions

Contact Tracing; Referral and Consultation

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Public Health; Environment and Public Health; Communicable Disease Control; Public Health Practice; Professional Practice; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Nora Rosenberg, PhD
• Organization: UNC Chapel Hill/UNC Project Lilongwe

Nora_Rosenberg@unc.edu

+265 (0)99 109 0676

Study Officials

• Nora E Rosenberg, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Mina Hosseinipour, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 15, 2014
• Study Start: March 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: August 7, 2017
• Results First Posted: August 7, 2017

Record last verified: 2016-09

Locations

MA (1)