NCT02085356

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,967

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
4 months until next milestone

Results Posted

Study results publicly available

February 21, 2019

Completed
Last Updated

February 21, 2019

Status Verified

January 1, 2019

Enrollment Period

4.6 years

First QC Date

March 10, 2014

Results QC Date

December 13, 2018

Last Update Submit

January 29, 2019

Conditions

HIVPregnancy

Keywords

HIVPMTCTSouth AfricaCouplesMale involvement

Outcome Measures

Primary Outcomes (2)

  • Dried Blood Spot Analysis of Medication Adherence- Mother and Infant

    Presence of prescribed PMTCT protocol medications among mothers will be assessed by dried blood spot at 32 weeks gestation.

    32 weeks gestation

  • Infant HIV Seroconversions

    Infants will be tested for HIV at 6 weeks per the South African standard of care and at 12 months per study protocol

    12 months postpartum

Secondary Outcomes (2)

  • Mother Reported Rates of Infant Exclusive Breastfeeding

    6 weeks

  • Attendance at Scheduled Ante and Postnatal Clinic Appointments

    6 months postpartum

Other Outcomes (1)

  • Self-reported Use of Condoms

    12 months postpartum

Study Arms (4)

Intervention women with partners

EXPERIMENTAL

Women will enroll with male partners and both members of the couple will attend the Protect your Family intervention

Behavioral: Protect your family

Intervention women without partners

EXPERIMENTAL

Women will enroll alone and will attend the Protect your Family Intervention without a partner

Behavioral: Protect your family

Control women with partners

NO INTERVENTION

Women will enroll with male partners and both members of the couple will attend time-matched video sessions

Control women alone

NO INTERVENTION

Women will enroll alone and will attend time-matched video sessions

Interventions

Protect your familyBEHAVIORAL

"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)

Intervention women with partnersIntervention women without partners

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Sciences Research Council

Pretoria, Gauteng, 0002, South Africa

Location

Related Publications (7)

  • Peltzer K, Abbamonte JM, Soni M, Rodriguez VJ, Lee TK, Weiss SM, Jones DL. Psychological and physical intimate partner violence and sexual risk behavior among South African couples: a dyadic analysis. AIDS Care. 2022 Dec;34(12):1610-1618. doi: 10.1080/09540121.2021.2016576. Epub 2021 Dec 18.

    PMID: 34927477DERIVED

  • Ramlagan S, Rodriguez VJ, Peltzer K, Ruiter RAC, Jones DL, Sifunda S. Self-Reported Long-Term Antiretroviral Adherence: A Longitudinal Study Among HIV Infected Pregnant Women in Mpumalanga, South Africa. AIDS Behav. 2019 Sep;23(9):2576-2587. doi: 10.1007/s10461-019-02563-z.

    PMID: 31228026DERIVED

  • Sifunda S, Peltzer K, Rodriguez VJ, Mandell LN, Lee TK, Ramlagan S, Alcaide ML, Weiss SM, Jones DL. Impact of male partner involvement on mother-to-child transmission of HIV and HIV-free survival among HIV-exposed infants in rural South Africa: Results from a two phase randomised controlled trial. PLoS One. 2019 Jun 5;14(6):e0217467. doi: 10.1371/journal.pone.0217467. eCollection 2019.

    PMID: 31166984DERIVED

  • Peltzer K, Babayigit S, Rodriguez VJ, Jean J, Sifunda S, Jones DL. Effect of a multicomponent behavioural PMTCT cluster randomised controlled trial on HIV stigma reduction among perinatal HIV positive women in Mpumalanga province, South Africa. SAHARA J. 2018 Dec;15(1):80-88. doi: 10.1080/17290376.2018.1510787.

    PMID: 30134772DERIVED

  • Jones DL, Rodriguez VJ, Mandell LN, Lee TK, Weiss SM, Peltzer K. Influences on Exclusive Breastfeeding Among Rural HIV-Infected South African Women: A Cluster Randomized Control Trial. AIDS Behav. 2018 Sep;22(9):2966-2977. doi: 10.1007/s10461-018-2197-z.

    PMID: 29926300DERIVED

  • Peltzer K, Weiss SM, Soni M, Lee TK, Rodriguez VJ, Cook R, Alcaide ML, Setswe G, Jones DL. A cluster randomized controlled trial of lay health worker support for prevention of mother to child transmission of HIV (PMTCT) in South Africa. AIDS Res Ther. 2017 Dec 16;14(1):61. doi: 10.1186/s12981-017-0187-2.

    PMID: 29248014DERIVED

  • Jones D, Peltzer K, Weiss SM, Sifunda S, Dwane N, Ramlagan S, Cook R, Matseke G, Maduna V, Spence A. Implementing comprehensive prevention of mother-to-child transmission and HIV prevention for South African couples: study protocol for a randomized controlled trial. Trials. 2014 Oct 27;15:417. doi: 10.1186/1745-6215-15-417.

    PMID: 25348459DERIVED

Results Point of Contact

Title
Violeta Rodriguez
Organization
University of Miami Miller School of Medicine
vjrodriguez@med.miami.edu
3052432188

Study Officials

  • Deborah L Jones, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

  • Karl Peltzer, PhD

    Human Sciences Research Council

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 12, 2014

Study Start

April 1, 2014

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

February 21, 2019

Results First Posted

February 21, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

Dissemination of findings will be made to the community participants and stakeholders. The US team and the South Africa team will collaborate and encourage community stakeholders to participate in dissemination and development of related research. Utilizing the data from this study, the collaborators will compile a research review document for the Government of South Africa. Successful results of this research will be used to develop a translational proposal based on empirical results. The study results will be disseminated through Dr. Peltzer, the South Africa PI. All investigators will work within the structure of the South Africa community sites to provide feedback to other medical providers and to the professional community by presentation of the results. Access to the database will be available under the supervision of the collaborators.

Locations

ZA(1)