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

September 26, 2011
January 20, 2014
September 2010
August 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01448512 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Promoting Male Involvement to Improve Prevention of Mother to Child Transmission (PMTCT) Uptake and Reduce Antenatal Infection
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.

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • HIV
  • Pregnancy
  • 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
  • Other: Usual Care
    4 time matched sessions focused on health education
    Other Name: Standard of Care
  • Usual Care
    Participation in 4 time matched sessions on health education topics
    Intervention: Other: Usual Care
  • Experimental: PartnerPlus intervention
    Four group counseling sessions focused on prevention of mother to child transmission (PMTCT) sexual risk reduction & adherence.
    Intervention: Behavioral: PartnerPlus Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
478
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT01448512
5P30AI073961-S, P30AI073961
No
Deborah Jones, University of Miami
University of Miami
National Institute of Allergy and Infectious Diseases (NIAID)
Study Director: Karl Peltzer, PhD Human Sciences Research Council
Principal Investigator: Deborah Jones, PhD University of Miami
University of Miami
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP