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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT02139176
First received: May 13, 2014
Last updated: November 14, 2014
Last verified: November 2014
  Purpose

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).


Condition Intervention
HIV
Behavioral: contract referral
Behavioral: patient referral

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Assessing Strategies for Increasing Male Involvement in Malawi's Antenatal Program

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Uptake of couple HIV counseling and testing [ Time Frame: three months ] [ Designated as safety issue: No ]
    It will be assessed 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). 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:
  • Female first Option B+ follow-up visit [ Time Frame: three months ] [ Designated as safety issue: No ]
    It will be assessed whether the female participants return for their first Option B+ visit (using the clinic's routine Option B+ records). Time to first visit will be assessed using a Kaplan Meier curve and a log rank test.

  • Male linkage to care [ Time Frame: one month ] [ Designated as safety issue: No ]
    It will be assessed whether 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. We will use the Kaplan Meier method to plot outcomes and a log rank test to compare time to linkage to care between arms.


Estimated Enrollment: 330
Study Start Date: March 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Patient referral
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
A patient agrees to recruit their partner using the invitation.
Other Names:
  • passive referral
  • patient notification
Experimental: contract referral
Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.
Behavioral: 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.
Other Names:
  • partner notification
  • contract partner notification
Behavioral: patient referral
A patient agrees to recruit their partner using the invitation.
Other Names:
  • passive referral
  • patient notification

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02139176

Contacts
Contact: Nora E Rosenberg, PhD +265 (0)99 109 0676 Nora_Rosenberg@unc.edu
Contact: Mina Hosseinipour, MD +265 (0)88 820 2153 mina_Hosseinipour@med.unc.edu

Locations
Malawi
Bwaila District Hospital Antenatal Unit Recruiting
Lilongwe, Central District, Malawi
Contact: Friday Saidi, MBBS       fsaidi@unclilongwe.org   
Contact: Tiwonge Mtande, BS    +265 (0)99 614 1000    tmtande@unclilongwe.org   
Principal Investigator: Friday Saidi, MBBS         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Nora E Rosenberg, PhD University of North Carolina, Chapel Hill
Principal Investigator: Mina Hosseinipour, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02139176     History of Changes
Other Study ID Numbers: 13-3707
Study First Received: May 13, 2014
Last Updated: November 14, 2014
Health Authority: Malawi: National Health Sciences Research Committee
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
couple HIV testing and counseling
disclosure
discordant
HIV
Malawi

ClinicalTrials.gov processed this record on November 25, 2014