Skip to main content
OpenTrials
Completed

NCT Number: NCT01448512

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Pregnancy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Sciences Research Council

Pretoria, Gauteng, South Africa

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Cognitive behavioral risk reduction intervention

Usual Care

Other

4 time matched sessions focused on health education

Other names: Standard of Care

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

    Time frame: Baseline, one month, 32 weeks, 3 days post partum

Secondary outcomes

  1. 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

  2. Mother and infant ARV prophylaxis

    Time frame: 3 days post partum

  3. 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

  4. Infant PCR

    Time frame: 6 weeks

  5. 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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

University of Miami Developmental Center for AIDs Research Promoting Male Involvement to Improve PMTCT Uptake and Reduce Antenatal Infection

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 7, 2011
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.