Implementing a Comprehensive Prevention of Mother-to-Child Transmission of HIV Program for South African Couples

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Miami
Sponsor:
Collaborators:
Human Sciences Research Council
Information provided by (Responsible Party):
Deborah Jones, University of Miami
ClinicalTrials.gov Identifier:
NCT02085356
First received: March 10, 2014
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

This study will test the effectiveness of a behavioral intervention to increase Prevention of Mother-to-Child Transmission of HIV (PMTCT) protocol uptake among South African HIV positive pregnant women. This study will also determine whether the participation of male partners will have additional positive impact on PMTCT uptake. The intervention will utilize a combination of both gender-concordant groups and individual or couples counseling strategies, before and after birth. During antenatal care, the intervention will use a gender-concordant group format to address PMTCT information, HIV disclosure, coping with stigma, intimate partner violence, and adherence to the overall PMTCT protocol. Just prior to birth and following birth, the intervention will shift to individual or couples-based counseling, targeting medication adherence, safer infant feeding, and family planning. It is hypothesized that women attending the intervention will be more likely to properly take HIV medication before birth and provide it to their infants. Additionally, it is hypothesized that male partner involvement will further increase the likelihood that mothers will take their HIV medication as prescribed and provide it to their infants.


Condition Intervention
HIV
Pregnancy
Behavioral: Protect your family

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Implementing Comprehensive PMTCT and HIV Prevention for South African Couples

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Dried blood spot analysis of medication adherence- Mother and Infant [ Time Frame: 32 weeks gestation/6 weeks postnatal ] [ Designated as safety issue: No ]
    Presence/absence of prescribed PMTCT protocol medications among mothers will be assessed by dried blood spot at 32 weeks gestation. Provision of ART to infants will be assessed at 6 weeks of age.

  • Infant HIV seroconversions [ Time Frame: 6 weeks postnatal and 12 months postpartum ] [ Designated as safety issue: No ]
    Infants will be tested for HIV at 6 weeks per the South African standard of care and at 12 months per study protocol


Secondary Outcome Measures:
  • Mother reported rates of infant exclusive breastfeeding [ Time Frame: 6 weeks and 6 months postpartum ] [ Designated as safety issue: No ]
    Feeding practices will be assessed at 6 weeks and 6 months postpartum, and rates of exclusive breastfeeding will be assessed

  • Attendance at scheduled ante and postnatal clinic appointments [ Time Frame: 32 weeks gestation, 6 weeks and 6 and 12 months postpartum ] [ Designated as safety issue: No ]
    Attendance at clinic appointments will be collected from patient records and self-report pre- and post-natal


Other Outcome Measures:
  • Self-reported use of condoms and "dual protection" [ Time Frame: 32 weeks gestation, 6 weeks and 6 and 12 months postpartum ] [ Designated as safety issue: No ]
    Sexual behavior (i.e., condom use, rates of dual protection postpartum) will be collected by participant self-report


Estimated Enrollment: 2160
Study Start Date: April 2014
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention women with partners
Women will enroll with male partners and both members of the couple will attend the Protect your Family intervention
Behavioral: Protect your family

"Protect Your Family" intervention is a manualized, closed, structured behavioral risk reduction program targeting HIV, stigma, disclosure, communication, intimate partner violence (IPV), PMTCT knowledge, safer conception, family planning and dual method sexual barrier use.

Intervention participants will attend 3 prenatal weekly 2 hour gender-specific (male or female, 5-7 participants) group sessions followed by 1 individual counseling session and 2 monthly couples or individual (women-only) counseling sessions (1 prenatal, 2 postpartum) led by study-trained clinic staff (e.g., nurses, HIV counseling and testing (HCT) counselors) plus standard of care (PMTCT)

Experimental: Intervention women without partners
Women will enroll alone and will attend the Protect your Family Intervention without a partner
Behavioral: Protect your family

"Protect Your Family" intervention is a manualized, closed, structured behavioral risk reduction program targeting HIV, stigma, disclosure, communication, intimate partner violence (IPV), PMTCT knowledge, safer conception, family planning and dual method sexual barrier use.

Intervention participants will attend 3 prenatal weekly 2 hour gender-specific (male or female, 5-7 participants) group sessions followed by 1 individual counseling session and 2 monthly couples or individual (women-only) counseling sessions (1 prenatal, 2 postpartum) led by study-trained clinic staff (e.g., nurses, HIV counseling and testing (HCT) counselors) plus standard of care (PMTCT)

No Intervention: Control women with partners
Women will enroll with male partners and both members of the couple will attend time-matched video sessions
No Intervention: Control women alone
Women will enroll alone and will attend time-matched video sessions

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV seropositive pregnant women with partners, 20-24 weeks pregnant (typical time of entry into antenatal clinic care), aged >18.
  • In Phase 2 (couples phase), both women and their partners will be enrolled. For the purposes of this study, primary male partners are defined as 1) husband, 2) current baby's father, or 3) current sexual partner.

Exclusion Criteria:

  • Persons actively psychotic (auditory or visual hallucination) or intoxicated (e.g., under the influence of alcohol of illegal drugs) will not be eligible and will be referred for treatment. Following resolution of symptoms, these persons will be eligible for the study. N.B.: Any person presenting for sessions actively psychotic or intoxicated will be referred for treatment and will not be eligible to participate in sessions until symptoms are resolved due to reduced likelihood of benefit from sessions.
  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: NCT02085356

Contacts
Contact: Deborah L Jones, PhD 3052432041 djones@med.miami.edu
Contact: Ryan R Cook 3052432188 rcook@med.miami.edu

Locations
South Africa
Human Sciences Research Council Recruiting
Pretoria, Gauteng, South Africa, 0002
Contact: Sibusiso Sifunda, PhD         
Principal Investigator: Karl Peltzer, PhD         
Sponsors and Collaborators
University of Miami
Human Sciences Research Council
Investigators
Principal Investigator: Deborah L Jones, PhD University of Miami
Principal Investigator: Karl Peltzer, PhD Human Sciences Research Council
  More Information

No publications provided

Responsible Party: Deborah Jones, Research Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02085356     History of Changes
Other Study ID Numbers: 20130238, 1R01HD078187
Study First Received: March 10, 2014
Last Updated: May 6, 2014
Health Authority: United States: Institutional Review Board
South Africa: Human Research Ethics Committee

Keywords provided by University of Miami:
HIV
PMTCT
South Africa
Couples
Male involvement

ClinicalTrials.gov processed this record on September 22, 2014