Clinical trial NCT03477279: Developing and Assessing a Male Engagement Intervention in Option B+ in Malawi
Official title: Developing and Assessing a Male Engagement Intervention in Option B+ in Malawi: A Randomized Controlled Trial in Lilongwe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Keywords: couple HIV testing and counseling
disclosure
Malawi
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-03-26
Enrollment: 1116
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria (HIV-infected Women):

* 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

Inclusion Criteria (Male Partners of HIV-infected women)

* \>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

Inclusion Criteria (HIV-uninfected Women):

* 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 (all Women and Male Partners):

• 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.

Primary outcomes:
measure: Number of Women Retained in Care
timeFrame: 12 months
measure: Number of Women With Viral Suppression
timeFrame: 12 months
measure: Number of HIV-positive Male Partners Aware of Their HIV-positive Status
timeFrame: 12 months
measure: Number of HIV-positive Male Partners Retained in Care
timeFrame: 12 months
measure: Number of HIV-positive Male Partners With Viral Suppression
timeFrame: 12 months
measure: Number of HIV-negative Men Without HIV Exposure From Their Primary Partner
timeFrame: 12 months
Secondary outcomes:
measure: Number of HIV-positive Female Participants Who Reported Early Infant Diagnosis
timeFrame: 12 months
measure: Predictors of Recent HIV Infection
timeFrame: At the day of female consent
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Bwaila District Hospital Antenatal Unit
state: Central District
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Nora E Rosenberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: