Developing and Assessing a Male Engagement Intervention in Option B+ in Malawi

NCT03477279 | Completed Results

• 2 other identifiers: 17-0681R00MH104154
• Study Type: interventional
• Target: 1,116
• Locations: 1 country
• Sites: 1

Brief Summary

There is promising evidence that couple-based approaches within Malawi's Option B+ prevention of mother to child transmission program could address help address 1) poor male engagement in the HIV continuum of care, 2) low male adoption of biomedical HIV prevention approaches, 3) sub-optimal female engagement in the continuum of care, and 4) poor or uncertain infant outcomes. Our team has developed an intervention to address these challenges, and will conduct a randomized controlled trial (N=500 couples) to assess intervention effectiveness at one year. Women with recent HIV infections enrolled in this trial will be compared against a cohort of 350 HIV-uninfected women to explore predictors of HIV acquisition in pregnancy in Malawi.

Conditions

Hiv

Keywords

couple HIV testing and counseling; disclosure; Malawi

Outcome Measures

Primary Outcomes (6)

• Number of Women Retained in Care

  Women who presented at 12 months and reported taking at least one dose of ART in the last seven days

  12 months

• Number of Women With Viral Suppression

  Women who presented at 12 months with a viral load \<1000 copies/mL

  12 months

• Number of HIV-positive Male Partners Aware of Their HIV-positive Status

  HIV-positive male partners who presented at 12 months and reported knowing they were HIV-positive prior to receiving the results of the HIV test conducted at the 12 month study visit

  12 months

• Number of HIV-positive Male Partners Retained in Care

  HIV-positive male partners who presented at 12 months and reported taking at least one dose of ART in the last seven days

  12 months

• Number of HIV-positive Male Partners With Viral Suppression

  HIV-positive male partners who presented at 12 months with a viral load \<1000 copies/mL

  12 months

• Number of HIV-negative Men Without HIV Exposure From Their Primary Partner

  HIV-negative men with a) consistent condom use in the last six months or b) a suppressed female partner or c) abstinence with primary partner

  12 months

Secondary Outcomes (2)

• Number of HIV-positive Female Participants Who Reported Early Infant Diagnosis

  12 months

• Predictors of Recent HIV Infection

  At the day of female consent

Study Arms (3)

Individual (SOC)

NO INTERVENTION

HIV-infected pregnant women enrolled in the individual arm of the study will receive Standard of Care Option B+ procedures.

Couple (Intervention)

EXPERIMENTAL

In addition to receiving standard of care procedures, HIV-infected pregnant women in the couple arm will be provided with an intervention aimed at recruiting their male partners, providing enhanced couple counseling and testing, engaging their male partners in their care, and supporting male partners to receive care and treatment services.

Behavioral: Enhanced Couple HIV Testing and Counseling

HIV-Uninfected Cohort

NO INTERVENTION

HIV-uninfected pregnant women will be invited to participate in a cross-sectional study. No intervention will be provided and no follow-up will be conducted.

Interventions

Enhanced Couple HIV Testing and Counseling BEHAVIORAL

Participants are provided study-specific partner referral cards and encouraged to bring male partners to antenatal care for a male engagement intervention. Those who do not present on their own are then traced. Couples will receive three enhanced couple counseling sessions that include: pre-test counseling, return of joint results, and post-test counseling. HIV-infected men will be able to initiate cART at the antenatal clinic and the couple will be offered condoms from the HTC counselor. Between sessions, couple members can pick up condoms and cART for one another.

Also known as: male engagement intervention

Couple (Intervention)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected and eligible for Option B+
• \>18 years old or 15-17 years old and married
• Planning to remain in the Bwaila catchment area for the next year or notify the study team if they leave the area or change facilities
• Part of a heterosexual relationship for \>3 months
• Expects the partner to be in the relevant catchment area for at least one week in the next six months.
• Able and willing to give locator information for this partner
• Willing to have study staff conduct phone and physical tracing of that partner
• Willing to undergo a couple-based intervention with this partner
• Able and willing to provide informed consent
• \>18 years old or 15-17 years old and married
• In a relationship with the female partner for \>3 months
• Willing to undergo a couples-based intervention with their female partner
• Able and willing to provide informed consent
• HIV-uninfected
• \>18 years old or 15-17 years old and married

You may not qualify if:

• Any condition that in the opinion of the study investigator would compromise the ability of the prospective participant to provide informed consent, undergo study procedures safely, or would prevent proper conduct of the study.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Bwaila District Hospital Antenatal Unit

Lilongwe, Central District, Malawi

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Counseling

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Nora Rosenberg, PhD, MSPH
• Organization: University of North Carolina at Chapel Hill

nora_rosenberg@unc.edu

919-843-6580

Study Officials

• Nora E Rosenberg, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: March 19, 2018
• First Posted: March 26, 2018
• Study Start: September 25, 2017
• Primary Completion: July 21, 2020
• Study Completion: September 30, 2020
• Last Updated: June 24, 2021
• Results First Posted: June 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)