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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.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02139176
Date of registration: 13/05/2014
Prospective Registration: No
Primary sponsor: University of North Carolina, Chapel Hill
Public title: Assessing Strategies for Increasing Male Involvement in Malawi's Antenatal Program
Scientific title: Assessing Strategies for Increasing Male Involvement in Malawi's Antenatal Program
Date of first enrolment: March 2014
Target sample size: 200
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02139176
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Malawi
Contacts
Name:     Nora E Rosenberg, PhD
Address: 
Telephone:
Email:
Affiliation:  University of North Carolina, Chapel Hill
Name:     Mina Hosseinipour, MD
Address: 
Telephone:
Email:
Affiliation:  University of North Carolina, Chapel Hill
Key inclusion & exclusion criteria

Inclusion Criteria:

- 18 years old or 16-17 years old and married

- Pregnant

- Received a positive HIV-test within the last day

- Will be in Lilongwe for the next month

- Able and willing to give locator information for >1 male partner in the Bwaila
District Hospital catchment area (either a mobile number, a physical address, or
both)

Exclusion Criteria:

- Enrolled/enrolling in the PROMISE study

- Initially Presenting with a male sex partner



Age minimum: 16 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
HIV
Intervention(s)
Behavioral: patient referral
Behavioral: contract referral
Primary Outcome(s)
Number of Women Who Came With Their Partners and Received Couple Counseling and Testing [Time Frame: three months]
Secondary Outcome(s)
Male Linkage to Care [Time Frame: one month from male presentation to the clinic]
Female First Option B+ Follow-up Visit [Time Frame: three months]
Secondary ID(s)
13-3707
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 07/08/2017
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02139176
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