Trial Outcomes & Findings for Implementing a Comprehensive Prevention of Mother-to-Child Transmission of HIV Program for South African Couples (NCT NCT02085356)
NCT ID: NCT02085356
Last Updated: 2019-02-21
Results Overview
Presence of prescribed PMTCT protocol medications among mothers will be assessed by dried blood spot at 32 weeks gestation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1967 participants
Primary outcome timeframe
32 weeks gestation
Results posted on
2019-02-21
Participant Flow
Participant milestones
| Measure |
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)
|
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)
|
Control Women With Partners
Women will enroll with male partners and both members of the couple will attend time-matched video sessions
|
Control Women Alone
Women will enroll alone and will attend time-matched video sessions
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
577
|
348
|
681
|
361
|
|
Overall Study
COMPLETED
|
577
|
348
|
681
|
361
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Implementing a Comprehensive Prevention of Mother-to-Child Transmission of HIV Program for South African Couples
Baseline characteristics by cohort
| Measure |
Intervention Women With Partners
n=577 Participants
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)
|
Intervention Women Without Partners
n=348 Participants
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)
|
Control Women With Partners
n=681 Participants
Women will enroll with male partners and both members of the couple will attend time-matched video sessions
|
Control Women Alone
n=361 Participants
Women will enroll alone and will attend time-matched video sessions
|
Total
n=1967 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30.24 years
STANDARD_DEVIATION 6.50 • n=99 Participants
|
28.33 years
STANDARD_DEVIATION 5.58 • n=107 Participants
|
30.60 years
STANDARD_DEVIATION 7.22 • n=206 Participants
|
28.60 years
STANDARD_DEVIATION 5.99 • n=7 Participants
|
29.73 years
STANDARD_DEVIATION 6.59 • n=31 Participants
|
|
Sex: Female, Male
Female
|
354 Participants
n=99 Participants
|
348 Participants
n=107 Participants
|
361 Participants
n=206 Participants
|
361 Participants
n=7 Participants
|
1424 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
223 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
320 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
543 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
577 Participants
n=99 Participants
|
348 Participants
n=107 Participants
|
681 Participants
n=206 Participants
|
361 Participants
n=7 Participants
|
1967 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
South Africa
|
577 participants
n=99 Participants
|
348 participants
n=107 Participants
|
681 participants
n=206 Participants
|
361 participants
n=7 Participants
|
1967 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 32 weeks gestationPopulation: 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.
Presence of prescribed PMTCT protocol medications among mothers will be assessed by dried blood spot at 32 weeks gestation.
Outcome measures
| Measure |
Intervention Women With Partners
n=67 Participants
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)
|
Intervention Women Without Partners
n=204 Participants
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)
|
Control Women With Partners
n=54 Participants
Women will enroll with male partners and both members of the couple will attend time-matched video sessions
|
Control Women Alone
n=242 Participants
Women will enroll alone and will attend time-matched video sessions
|
|---|---|---|---|---|
|
Dried Blood Spot Analysis of Medication Adherence- Mother and Infant
|
56 Participants
|
157 Participants
|
35 Participants
|
183 Participants
|
PRIMARY outcome
Timeframe: 12 months postpartumPopulation: 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.
Infants will be tested for HIV at 6 weeks per the South African standard of care and at 12 months per study protocol
Outcome measures
| Measure |
Intervention Women With Partners
n=300 Participants
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)
|
Intervention Women Without Partners
n=249 Participants
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)
|
Control Women With Partners
n=306 Participants
Women will enroll with male partners and both members of the couple will attend time-matched video sessions
|
Control Women Alone
n=265 Participants
Women will enroll alone and will attend time-matched video sessions
|
|---|---|---|---|---|
|
Infant HIV Seroconversions
|
0 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: This refers to exclusive breastfeeding as reported by the mother.
Feeding practices will be assessed at 6 weeks, and rates of exclusive breastfeeding will be assessed.
Outcome measures
| Measure |
Intervention Women With Partners
n=191 Participants
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)
|
Intervention Women Without Partners
n=137 Participants
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)
|
Control Women With Partners
n=259 Participants
Women will enroll with male partners and both members of the couple will attend time-matched video sessions
|
Control Women Alone
n=192 Participants
Women will enroll alone and will attend time-matched video sessions
|
|---|---|---|---|---|
|
Mother Reported Rates of Infant Exclusive Breastfeeding
|
102 Participants
|
71 Participants
|
169 Participants
|
132 Participants
|
SECONDARY outcome
Timeframe: 6 months postpartumPopulation: Attendance records could not be retrieved for most participants. However, this analysis was still conducted among those participants who had data.
Attendance at clinic appointments will be collected from patient records and self-report pre- and post-natal
Outcome measures
| Measure |
Intervention Women With Partners
n=111 Participants
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)
|
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)
|
Control Women With Partners
n=215 Participants
Women will enroll with male partners and both members of the couple will attend time-matched video sessions
|
Control Women Alone
Women will enroll alone and will attend time-matched video sessions
|
|---|---|---|---|---|
|
Attendance at Scheduled Ante and Postnatal Clinic Appointments
|
99 Participants
|
0 Participants
|
187 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months postpartumSexual behavior (i.e., condom use) will be collected by participant self-report
Outcome measures
| Measure |
Intervention Women With Partners
n=381 Participants
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)
|
Intervention Women Without Partners
n=198 Participants
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)
|
Control Women With Partners
n=535 Participants
Women will enroll with male partners and both members of the couple will attend time-matched video sessions
|
Control Women Alone
n=226 Participants
Women will enroll alone and will attend time-matched video sessions
|
|---|---|---|---|---|
|
Self-reported Use of Condoms
|
278 Participants
|
164 Participants
|
433 Participants
|
185 Participants
|
Adverse Events
Intervention Women With Partners
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Intervention Women Without Partners
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Control Women With Partners
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Women Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Violeta Rodriguez
University of Miami Miller School of Medicine
Phone: 3052432188
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place