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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 March 2021 |
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Main ID: |
NCT03477279 |
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Date of registration:
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19/03/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Developing and Assessing a Male Engagement Intervention in Option B+ in Malawi
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Scientific title:
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Developing and Assessing a Male Engagement Intervention in Option B+ in Malawi: A Randomized Controlled Trial in Lilongwe |
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Date of first enrolment:
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September 25, 2017 |
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Target sample size:
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1116 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03477279 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Malawi
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Contacts
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Name:
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Nora E Rosenberg, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of North Carolina, Chapel Hill |
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Key inclusion & exclusion criteria
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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.
Age minimum:
15 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hiv
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Intervention(s)
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Behavioral: Enhanced Couple HIV Testing and Counseling
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Primary Outcome(s)
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Male prevention
[Time Frame: One year]
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Male viral suppression
[Time Frame: One year from female enrollment]
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Female viral suppression
[Time Frame: One year]
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Secondary Outcome(s)
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HIV-free infant survival
[Time Frame: At the time of early infant diagnosis (approximately 6 weeks after birth)]
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Predictors of recent HIV infection
[Time Frame: Baseline]
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Secondary ID(s)
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17-0681
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R00MH104154
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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