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

NCT01448512 | Completed

• 2 other identifiers: 5P30AI073961-SP30AI073961
• Study Type: interventional
• Target: 478
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV; Pregnancy

Keywords

HIV; Pregnancy; Prevention; Couples

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Change in Mother, father, infant HIV VCT from baseline to one month to 3 days post partum

  Baseline, one month, 3 days post partum

• Mother and infant ARV prophylaxis

  3 days post partum

• Change in Maternal PMTCT ARV uptake from baseline to 32 weeks to 3 days post partum

  Baseline, 32 weeks, 3 days post partum

• Infant PCR

  6 weeks

• Change in rate of condom use from baseline to one month to 3 days post partum

  Baseline, one month, 3 days post partum

Study Arms (2)

Usual Care

OTHER

Participation in 4 time matched sessions on health education topics

Other: Usual Care

PartnerPlus intervention

EXPERIMENTAL

Four group counseling sessions focused on prevention of mother to child transmission (PMTCT) sexual risk reduction \& adherence.

Behavioral: PartnerPlus Intervention

Interventions

PartnerPlus Intervention BEHAVIORAL

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.

Also known as: Cognitive behavioral risk reduction intervention

PartnerPlus intervention

Usual Care OTHER

4 time matched sessions focused on health education

Also known as: Standard of Care

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Single mothers not being tested for HIV at the ANC

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Human Sciences Research Council

Pretoria, Gauteng, South Africa

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Karl Peltzer, PhD

  Human Sciences Research Council

  STUDY DIRECTOR

• Deborah Jones, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: October 7, 2011
• Study Start: September 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

ZA (1)