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

NCT ID: NCT03477279

Last Updated: 2021-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-25
• Study Completion Date: 2020-09-30

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.

Detailed Description

In sub-Saharan Africa, engaging HIV-infected men in HIV care and treatment and engaging HIV-uninfected men in prevention has proven challenging. Along all steps of the HIV care-seeking cascade, men exhibit worse care-seeking behaviors. They are less likely to seek HIV testing and counseling (HTC), initiate combination antiretroviral therapy (cART), and be retained in cART care. Poor care-seeking has resulted in a lower prevalence of viral suppression and earlier mortality. Additionally, men rarely engage in the antenatal care-seeking of their female sexual partners, leading to worse maternal and infant outcomes. This low level of engagement has been noted in Malawi's Option B+ prevention of mother to child transmission (PMTCT) program, and has been a critical barrier to female Option B+ uptake and retention, and a missed opportunity for engaging men.

There is promising evidence that couple-based approaches within Malawi's Option B+ prevention of mother to child transmission program could address all of these challenges: poor male engagement in the HIV continuum of care, low male adoption of biomedical HIV prevention approaches, sub-optimal female engagement in the continuum of care, and poor or uncertain infant outcomes. Our team has designed a couples-based intervention to address these challenges, and will conduct a randomized controlled trial (N=500 couples) to assess intervention effectiveness at one year. Results from this study are expected to inform how best to address family outcomes in an Option B+ program.

This study has the following aims described below:

Aim 1: Determine whether the couple-based intervention increases new HIV-positive diagnoses among HIV-infected male sex partners, helps HIV-infected men engage and remain in care, and contributes to male viral suppression compared to individual standard of care. The investigators will compare the couple-based intervention to standard of care for increasing the proportion of men who are aware of being HIV-infected, the proportion of these men who initiate and remain in cART care, and the proportion of these men with viral suppression at one year.

Aim 2: Determine whether the couple-based intervention identifies HIV-discordant couples and decreases the likelihood of male exposure to HIV compared to individual standard of care. The investigators will compare the intervention to standard of care for increasing the number of men with non-HIV exposure from their female partner through consistent condom use, viral suppression, abstinence, or a combination of these methods over one year.

Aim 3: Determine whether the couple-based intervention improves female cART retention and viral suppression compared to individual standard of care. The investigators will compare the intervention to standard of care for female cART retention and viral suppression at one year.

Aim 4: Determine whether the couple-based intervention improves infant early infant diagnosis uptake compared to individual standard of care. Explore uptake of early infant diagnosis and rates of mother-to-child transmission and child survival in the two intervention arms.

Aim 5: Develop an in-depth understanding of HIV transmission dynamics in Lilongwe. Using the biomarkers and behavioral survey, we will seek to understand transmission timing, direction, and context in Lilongwe. We will compare women with recent HIV infection to a population of HIV-uninfected controls (n=350) to understand predictors of HIV acquisition in pregnancy in Malawi.

Conditions

Hiv

Study Design

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

Study Groups

Individual (SOC)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Couple (Intervention)

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.

Group Type: EXPERIMENTAL

Enhanced Couple HIV Testing and Counseling

Intervention Type: 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.

HIV-Uninfected Cohort

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Enhanced Couple HIV Testing and Counseling

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

male engagement intervention

Eligibility Criteria

Inclusion Criteria

• 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
• 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.
• Willing to receive couples-based HIV testing and counseling with this partner
• Able and willing to provide informed consent

Exclusion Criteria

• 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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

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

Locations

Bwaila District Hospital Antenatal Unit

Lilongwe, Central District, Malawi

Countries

Malawi

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R00MH104154

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-0681

Identifier Type: -

Identifier Source: org_study_id