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Trial record 8 of 110 for:    test | ( Map: Malawi )

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

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ClinicalTrials.gov Identifier: NCT03477279
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Hiv Behavioral: Enhanced Couple HIV Testing and Counseling Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Developing and Assessing a Male Engagement Intervention in Option B+ in Malawi: A Randomized Controlled Trial in Lilongwe
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: Individual (SOC)
Women enrolled in the individual arm of the study will receive Standard of Care Option B+ procedures.
Experimental: Couple (Intervention)
In addition to receiving standard of care procedures, 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

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.

Other Name: male engagement intervention




Primary Outcome Measures :
  1. Female viral suppression [ Time Frame: One year ]
    The proportion of women with undetectable HIV virus.

  2. Male viral suppression [ Time Frame: One year from female enrollment ]
    The proportion of HIV infected men in each arm with undetectable HIV virus.

  3. Male prevention [ Time Frame: One year ]
    The proportion of HIV-uninfected men who report continuous and consistent HIV prevention behaviors


Secondary Outcome Measures :
  1. HIV-free infant survival [ Time Frame: At the time of early infant diagnosis (approximately 6 weeks after birth) ]
    The proportion of infants who are alive and HIV-free



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (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)

  • >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

Exclusion Criteria (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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477279


Contacts
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Contact: Tiwonge Mtande, BSc +265 (0)996141000 tmtande@unclilongwe.org
Contact: Lauren Graybill, MSc lag111@email.unc.edu

Locations
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Malawi
Bwaila District Hospital Antenatal Unit Recruiting
Lilongwe, Central District, Malawi
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Nora E Rosenberg, PhD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03477279     History of Changes
Other Study ID Numbers: 17-0681
R00MH104154 ( U.S. NIH Grant/Contract )
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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