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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Deborah Jones, University of Miami
ClinicalTrials.gov Identifier:
NCT01448512
First received: September 26, 2011
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
HIV
Pregnancy
Behavioral: PartnerPlus Intervention
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: University of Miami Developmental Center for AIDs Research Promoting Male Involvement to Improve PMTCT Uptake and Reduce Antenatal Infection

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Mother and infant ARV prophylaxis [ Time Frame: 3 days post partum ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Infant PCR [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 478
Study Start Date: September 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Usual Care
Participation in 4 time matched sessions on health education topics
Other: Usual Care
4 time matched sessions focused on health education
Other Name: 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 Name: Cognitive behavioral risk reduction intervention

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448512

Locations
South Africa
Human Sciences Research Council
Pretoria, Gauteng, South Africa
Sponsors and Collaborators
University of Miami
Investigators
Study Director: Karl Peltzer, PhD Human Sciences Research Council
Principal Investigator: Deborah Jones, PhD University of Miami
  More Information

No publications provided

Responsible Party: Deborah Jones, Research Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01448512     History of Changes
Other Study ID Numbers: 5P30AI073961-S, P30AI073961
Study First Received: September 26, 2011
Last Updated: January 20, 2014
Health Authority: United States: Federal Government
South Africa: National Health Research Ethics Council

Keywords provided by University of Miami:
HIV
Pregnancy
Prevention
Couples

ClinicalTrials.gov processed this record on November 24, 2014