Clinical trial NCT01448512: Promoting Male Involvement to Improve Prevention of Mother to Child Transmission (PMTCT) Uptake and Reduce Antenatal Infection
Official title: University of Miami Developmental Center for AIDs Research Promoting Male Involvement to Improve PMTCT Uptake and Reduce Antenatal Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Pregnancy
Keywords: HIV
Pregnancy
Prevention
Couples
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2011-10-07
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
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
timeFrame: Baseline, one month, 32 weeks, 3 days post partum
Secondary outcomes:
measure: Change in Mother, father, infant HIV VCT from baseline to one month to 3 days post partum
timeFrame: Baseline, one month, 3 days post partum
measure: Mother and infant ARV prophylaxis
timeFrame: 3 days post partum
measure: Change in Maternal PMTCT ARV uptake from baseline to 32 weeks to 3 days post partum
timeFrame: Baseline, 32 weeks, 3 days post partum
measure: Infant PCR
timeFrame: 6 weeks
measure: Change in rate of condom use from baseline to one month to 3 days post partum
timeFrame: Baseline, one month, 3 days post partum
Other outcomes:
Locations:
city: Pretoria
country: South Africa
facility: Human Sciences Research Council
state: Gauteng
Study officials:
affiliation: Human Sciences Research Council
name: Karl Peltzer, PhD
role: STUDY_DIRECTOR
affiliation: University of Miami
name: Deborah Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: