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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448512
• Other study ID #: 5P30AI073961-S
• Secondary ID: P30AI073961
• Status: Completed
• Phase: N/A
• First received: September 26, 2011
• Last updated: January 20, 2014
• Start date: September 2010
• Est. completion date: August 2012

Study information

• Verified date: January 2014
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentSouth Africa: National Health Research Ethics Council
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 478
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• Pregnancy

Intervention

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:
• Usual Care
4 time matched sessions focused on health education

Locations

Country	Name	City	State
South Africa	Human Sciences Research Council	Pretoria	Gauteng

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Baseline, one month, 32 weeks, 3 days post partum	No
Secondary	Change in Mother, father, infant HIV VCT from baseline to one month to 3 days post partum		Baseline, one month, 3 days post partum	No
Secondary	Mother and infant ARV prophylaxis		3 days post partum	No
Secondary	Change in Maternal PMTCT ARV uptake from baseline to 32 weeks to 3 days post partum		Baseline, 32 weeks, 3 days post partum	No
Secondary	Infant PCR		6 weeks	No
Secondary	Change in rate of condom use from baseline to one month to 3 days post partum		Baseline, one month, 3 days post partum	No