Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 110 for:    test | ( Map: Malawi )

Assessing Strategies for Increasing Male Involvement in Malawi's Antenatal Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02139176
Recruitment Status : Completed
First Posted : May 15, 2014
Results First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition HIV
Interventions Behavioral: contract referral
Behavioral: patient referral
Enrollment 200
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patient Referral Contract Referral
Hide Arm/Group Description

Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information

patient referral: A patient agrees to recruit their partner using the invitation.

Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.

contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.

patient referral: A patient agrees to recruit their partner using the invitation.

Period Title: Overall Study
Started 100 100
Completed 100 100
Not Completed 0 0
Arm/Group Title Patient Referral Contract Referral Total
Hide Arm/Group Description

Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information

patient referral: A patient agrees to recruit their partner using the invitation.

Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.

contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.

patient referral: A patient agrees to recruit their partner using the invitation.

Total of all reporting groups
Overall Number of Baseline Participants 100 100 200
Hide Baseline Analysis Population Description
HIV-infected women eligible for Option B+
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 100 participants 200 participants
26.5  (0.49) 26.6  (0.50) 26.6  (0.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Female
100
 100.0%
100
 100.0%
200
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Women Who Came With Their Partners and Received Couple Counseling and Testing
Hide Description Based on whether the female partner brings her male partner to the antenatal clinic for couple HIV counseling and testing (as recorded on study case report forms) as the primary measure of uptake. We will compare time to couple HIV counseling and testing between groups using the Kaplan Meier method and a log rank test.
Time Frame three months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patient Referral Contract Referral
Hide Arm/Group Description:

Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information

patient referral: A patient agrees to recruit their partner using the invitation.

Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.

contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.

Overall Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: Female participants receiving CHTC
52 70
2.Secondary Outcome
Title Female First Option B+ Follow-up Visit
Hide Description It will be assessed whether the female participants return for their first Option B+ visit (using the clinic's routine Option B+ records). The number retained will be compared.
Time Frame three months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patient Referral Contract Referral
Hide Arm/Group Description:

Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information

patient referral: A patient agrees to recruit their partner using the invitation.

Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.

Contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.

Overall Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: participants
83 91
3.Secondary Outcome
Title Male Linkage to Care
Hide Description It will be assessed whether newly diagnosed HIV-infected male partners are linked to care within one month of learning their HIV positive result with their partner. This will be assessed from abstraction of routine clinic records at Martin Preuss Center.
Time Frame one month from male presentation to the clinic
Hide Outcome Measure Data
Hide Analysis Population Description
These are only the HIV-infected men who participated in the study who were HIV-infected and not already engaged in care. That is why it is only a subset of the larger population.
Arm/Group Title Patient Referral Contract Referral
Hide Arm/Group Description:

Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information

patient referral: A patient agrees to recruit their partner using the invitation.

Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.

contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.

Overall Number of Participants Analyzed 26 33
Measure Type: Number
Unit of Measure: partners linked to care
5 15
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patient Referral Contract Referral
Hide Arm/Group Description

Women are given an invitation to give to a male partner inviting them to come to the clinic for important pregnancy information

patient referral: A patient agrees to recruit their partner using the invitation.

Same as control. However, if the male partner does not present, a community worker will trace the partner in the community.

contract referral: A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.

All-Cause Mortality
Patient Referral Contract Referral
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Patient Referral Contract Referral
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/100 (0.00%)      0/100 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patient Referral Contract Referral
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/100 (0.00%)      3/100 (3.00%)    
Social circumstances     
social disruptions reported by women  [1]  0/100 (0.00%)  0 3/100 (3.00%)  3
social disruption reported by men * [2]  0/100 (0.00%)  0 1/100 (1.00%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Two couples separated and the woman reported this One female participant felt blamed for bringing HIV into the relationship and she reported this One male participant was upset when he misunderstood which partner he was being called about.
[2]
Men who reported disruptions related to tracing or study participation.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Nora Rosenberg, PhD
Organization: UNC Chapel Hill/UNC Project Lilongwe
Phone: +265 (0)99 109 0676
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02139176     History of Changes
Other Study ID Numbers: 13-3707
First Submitted: May 13, 2014
First Posted: May 15, 2014
Results First Submitted: September 2, 2015
Results First Posted: August 7, 2017
Last Update Posted: August 7, 2017