Promoting Male Involvement to Improve Prevention of Mother to Child Transmission (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 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|
- 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 ]
- 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 ]
|Study Start Date:||September 2010|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
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
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448512
|Human Sciences Research Council|
|Pretoria, Gauteng, South Africa|
|Study Director:||Karl Peltzer, PhD||Human Sciences Research Council|
|Principal Investigator:||Deborah Jones, PhD||University of Miami|