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

Implementing Comprehensive PMTCT and HIV Prevention for South African Couples

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02085356
Enrollment
1967
Registered
2014-03-12
Start date
2014-04-30
Completion date
2018-11-30
Last updated
2019-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Pregnancy

Keywords

HIV, PMTCT, South Africa, Couples, Male involvement

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.

Detailed description

Abstract. In rural South Africa, only two-thirds of HIV+ pregnant women seeking antenatal care at community health centers took full advantage of available prevention of mother-to-child transmission (PMTCT) services in 2010 (SADOH). While engagement of male partners has been encouraged as a potential means of increasing PMTCT uptake, men have been reluctant to accompany their wives/partners to antenatal care. Recent studies generally support male involvement in promoting PMTCT, but the nature and impact of that involvement is unclear and untested. It is also clear that factors such as stigma, disclosure and intimate partner violence pose significant barriers to PMTCT uptake and retention in care, suggesting that male involvement may be necessary, but not sufficient to accomplish the WHO goal of \<5% infant HIV incidence. Additional measures may be needed to increase participation by HIV positive pregnant women in PMTCT. In 2011, Mpumalanga Province had the highest rates of HIV in the country (36.7%) and rates of infant HIV incidence in rural clinics ranged up to 50%. Rates of PMTCT uptake in the Province have been among the lowest in South Africa (69%). This application proposes to expand on a successful PEPFAR- supported, PMTCT couples intervention pilot study conducted in Mpumalanga Province, (Vikela Umndeni: Protect Your Family) to include a more representative population of HIV positive pregnant women and their partners, the primary objective being to determine whether male partner involvement plus a behavioral intervention would significantly reduce infant HIV incidence by increasing levels of adherence to ARV/ PMTCT protocols, including breastfeeding and family planning, during the antenatal and post-natal periods. The proposed study will enroll two cohorts of HIV positive pregnant women recruited from 12 randomly assigned Community Health Centers (6 experimental, 6 control): a) Women attending without their male partners (n = 720), followed by b) Women attending with their male partners (n = 720 couples), to determine whether the influence of male participation itself or combined with a behavioral PMTCT intervention can significantly reduce infant HIV infection ante-, peri- and post-natally. It is our intention to significantly increase PMTCT participation from current levels (69%) in Mpumalanga Province to 90-95% through engaging women and couples in a unique, controlled, six session ante- and post-natal risk-reducing/PMTCT promotion intervention addressing the barriers to PMTCT (e.g., stigma, disclosure, intimate partner violence, communication, infant feeding practices, safer conception) that prevent women and men from taking full advantage of the treatment opportunities available to them and their infants. Based upon the encouraging preliminary results from our pilot study, successful CHC adoption of the Vikela Umndeni: Protect Your Family program could have major public health policy implications for containing the epidemic among the most vulnerable populations in rural South Africa: HIV+ pregnant women and their infants.

Interventions

BEHAVIORALProtect 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)

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Human Sciences Research Council
CollaboratorOTHER_GOV
University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Dried Blood Spot Analysis of Medication Adherence- Mother and Infant32 weeks gestationPresence of prescribed PMTCT protocol medications among mothers will be assessed by dried blood spot at 32 weeks gestation.
Infant HIV Seroconversions12 months postpartumInfants will be tested for HIV at 6 weeks per the South African standard of care and at 12 months per study protocol

Secondary

MeasureTime frameDescription
Mother Reported Rates of Infant Exclusive Breastfeeding6 weeksFeeding practices will be assessed at 6 weeks, and rates of exclusive breastfeeding will be assessed.
Attendance at Scheduled Ante and Postnatal Clinic Appointments6 months postpartumAttendance at clinic appointments will be collected from patient records and self-report pre- and post-natal

Other

MeasureTime frameDescription
Self-reported Use of Condoms12 months postpartumSexual behavior (i.e., condom use) will be collected by participant self-report

Countries

South Africa

Participant flow

Participants by arm

ArmCount
Intervention Women With Partners
Women will enroll with male partners and both members of the couple will attend the Protect your Family intervention 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)
577
Intervention Women Without Partners
Women will enroll alone and will attend the Protect your Family Intervention without a partner 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)
348
Control Women With Partners
Women will enroll with male partners and both members of the couple will attend time-matched video sessions
681
Control Women Alone
Women will enroll alone and will attend time-matched video sessions
361
Total1,967

Baseline characteristics

CharacteristicIntervention Women With PartnersTotalControl Women AloneControl Women With PartnersIntervention Women Without Partners
Age, Continuous30.24 years
STANDARD_DEVIATION 6.5
29.73 years
STANDARD_DEVIATION 6.59
28.60 years
STANDARD_DEVIATION 5.99
30.60 years
STANDARD_DEVIATION 7.22
28.33 years
STANDARD_DEVIATION 5.58
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
577 Participants1967 Participants361 Participants681 Participants348 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
South Africa
577 participants1967 participants361 participants681 participants348 participants
Sex: Female, Male
Female
354 Participants1424 Participants361 Participants361 Participants348 Participants
Sex: Female, Male
Male
223 Participants543 Participants0 Participants320 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
1 / 5772 / 3480 / 6811 / 361
other
Total, other adverse events
0 / 5770 / 3480 / 6810 / 361
serious
Total, serious adverse events
0 / 5770 / 3480 / 6810 / 361

Outcome results

Primary

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.

Time frame: 32 weeks gestation

Population: The presence of medications via dried blood spot at 32 weeks gestation was only assessed in women, not infants, given that dried blood spots were not collected from infants.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention Women With PartnersDried Blood Spot Analysis of Medication Adherence- Mother and Infant56 Participants
Intervention Women Without PartnersDried Blood Spot Analysis of Medication Adherence- Mother and Infant157 Participants
Control Women With PartnersDried Blood Spot Analysis of Medication Adherence- Mother and Infant35 Participants
Control Women AloneDried Blood Spot Analysis of Medication Adherence- Mother and Infant183 Participants
Primary

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

Time frame: 12 months postpartum

Population: Medical records for tests at 6 weeks were lost by the participating clinics and therefore, medical records were considered to be unreliable. Therefore, the reported results are based on 12-month tests.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention Women With PartnersInfant HIV Seroconversions0 Participants
Intervention Women Without PartnersInfant HIV Seroconversions4 Participants
Control Women With PartnersInfant HIV Seroconversions0 Participants
Control Women AloneInfant HIV Seroconversions4 Participants
Secondary

Attendance at Scheduled Ante and Postnatal Clinic Appointments

Attendance at clinic appointments will be collected from patient records and self-report pre- and post-natal

Time frame: 6 months postpartum

Population: Attendance records could not be retrieved for most participants. However, this analysis was still conducted among those participants who had data.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention Women With PartnersAttendance at Scheduled Ante and Postnatal Clinic Appointments99 Participants
Intervention Women Without PartnersAttendance at Scheduled Ante and Postnatal Clinic Appointments0 Participants
Control Women With PartnersAttendance at Scheduled Ante and Postnatal Clinic Appointments187 Participants
Comparison: Attendance records could not be retrieved for most participants. However, this analysis was still conducted among those participants who had data.p-value: 0.902Chi-squared
Secondary

Mother Reported Rates of Infant Exclusive Breastfeeding

Feeding practices will be assessed at 6 weeks, and rates of exclusive breastfeeding will be assessed.

Time frame: 6 weeks

Population: This refers to exclusive breastfeeding as reported by the mother.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention Women With PartnersMother Reported Rates of Infant Exclusive Breastfeeding102 Participants
Intervention Women Without PartnersMother Reported Rates of Infant Exclusive Breastfeeding71 Participants
Control Women With PartnersMother Reported Rates of Infant Exclusive Breastfeeding169 Participants
Control Women AloneMother Reported Rates of Infant Exclusive Breastfeeding132 Participants
p-value: 0.605Mixed Models Analysis
Other Pre-specified

Self-reported Use of Condoms

Sexual behavior (i.e., condom use) will be collected by participant self-report

Time frame: 12 months postpartum

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention Women With PartnersSelf-reported Use of Condoms278 Participants
Intervention Women Without PartnersSelf-reported Use of Condoms164 Participants
Control Women With PartnersSelf-reported Use of Condoms433 Participants
Control Women AloneSelf-reported Use of Condoms185 Participants
p-value: 0.869Mixed Models Analysis
p-value: 0.982Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026