Promoting Male Involvement to Improve Prevention of Mother to Child Transmission (PMTCT) Uptake and Reduce Antenatal Infection

January 20, 2014 updated by: Deborah Jones, University of Miami

University of Miami Developmental Center for AIDs Research Promoting Male Involvement to Improve PMTCT Uptake and Reduce Antenatal Infection

This study will evaluate the impact of combining two evidence-based interventions: a couples risk reduction intervention with an evidence based medication adherence intervention designed to enhance male participation in combination with improving medication and prevention of mother to child transmission (PMTCT) adherence in antenatal clinics (ANCs). Clinics will be randomly assigned to experimental and control conditions and effectiveness of the combined intervention to enhance PMTCT as well as reduce antenatal seroconversion by both individuals and clinics will be examined. It is hypothesized that community clinics implementing PartnerPlus will have more effective PMTCT program adherence, as measured by total participant 1) maternal and paternal ANC and PartnerPlus visits, 2) maternal and paternal human immunodeficiency virus (HIV) Counseling & Testing (HCT) uptake, 3) maternal and infant antiretroviral (ARV) prophylaxis uptake, 4) maternal highly active antiretroviral therapy (HAART) uptake, 5) infant polymerase chain reaction (PCR) for HIV, and 5) maternal and infant HIV serostatus and that community clinics implementing PartnerPlus will have reduced sexual risk behavior, as measured by participant sexual barrier use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a group-randomized controlled trial using a 2 x 6 comparison (Clinic, Experimental, Control x Time, Baseline, Post-Intervention, Pre-delivery 32 weeks, Pre-delivery day, Delivery, Post Partum). Twelve community health centers (CHCs) in communities within the Gert Sibande and Nkangala Districts in Mpumalanga, South Africa (SA) will be randomly assigned to condition in a 1:1 ratio. Six usual care condition clinics will provide the standard of care, PMTCT; six experimental condition clinics will offer PartnerPlus to mothers completing HIV testing, regardless of serostatus, who are willing to enroll with their male partners and participate in the integrated PartnerPlus intervention. This study will recruit 240 couples (n = 480 individuals); community clinics will recruit 2 cohort per clinic over 3 months (10 couples per cohort, n = 40, 120 individuals per condition).

Study Type

Interventional

Enrollment (Actual)

478

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa
        • Human Sciences Research Council

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • pregnant women age 18 and older who have received HCT (HIC Counseling & Testing) at the antenatal clinic (ANC),
  • willing to attend PartnerPlus or prevention of mother to child transmission (PMTCT) visits with their male partners,
  • male partners must also be available to participate and
  • both partners must be willing to participate in the study.
  • All participants will be current adult residents of Mpumalanga Province and agree to be attend four group sessions, 2 psychosocial assessments and 1 three day post-delivery assessment (maternal and infant blood sample).

Exclusion Criteria:

  • Single mothers not being tested for HIV at the ANC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Usual Care
Participation in 4 time matched sessions on health education topics
Other: Usual Care
4 time matched sessions focused on health education
Other Names:
  • Standard of Care
Experimental: PartnerPlus intervention
Four group counseling sessions focused on prevention of mother to child transmission (PMTCT) sexual risk reduction & adherence.
Behavioral: PartnerPlus Intervention
The intervention employs a closed, structured, group intervention limited to 10 participants (women or men). Four weekly, 11/2-2 hour sessions are led by a trained gender-congruent counselor and a peer facilitator and emphasize group participation, cognitive-behavioral skill building, sexual negotiation and experimentation with products.
Other Names:
  • Cognitive behavioral risk reduction intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in number of ANC visits by mother and father from baseline to one month post intervention to 32 weeks to 3 days post partum
Time Frame: Baseline, one month, 32 weeks, 3 days post partum
Baseline, one month, 32 weeks, 3 days post partum

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Mother, father, infant HIV VCT from baseline to one month to 3 days post partum
Time Frame: Baseline, one month, 3 days post partum
Baseline, one month, 3 days post partum
Mother and infant ARV prophylaxis
Time Frame: 3 days post partum
3 days post partum
Change in Maternal PMTCT ARV uptake from baseline to 32 weeks to 3 days post partum
Time Frame: Baseline, 32 weeks, 3 days post partum
Baseline, 32 weeks, 3 days post partum
Infant PCR
Time Frame: 6 weeks
6 weeks
Change in rate of condom use from baseline to one month to 3 days post partum
Time Frame: Baseline, one month, 3 days post partum
Baseline, one month, 3 days post partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Director: Karl Peltzer, PhD, Human Sciences Research Council
  • Principal Investigator: Deborah Jones, PhD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

September 26, 2011

First Submitted That Met QC Criteria

October 6, 2011

First Posted (Estimate)

October 7, 2011

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 20, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5P30AI073961-S
  • P30AI073961 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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