HIV, Pregnancy
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Dried Blood Spot Analysis of Medication Adherence- Mother and Infant | 32 weeks gestation | Presence of prescribed PMTCT protocol medications among mothers will be assessed by dried blood spot at 32 weeks gestation. |
| Infant HIV Seroconversions | 12 months postpartum | Infants will be tested for HIV at 6 weeks per the South African standard of care and at 12 months per study protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mother Reported Rates of Infant Exclusive Breastfeeding | 6 weeks | Feeding practices will be assessed at 6 weeks, and rates of exclusive breastfeeding will be assessed. |
| Attendance at Scheduled Ante and Postnatal Clinic Appointments | 6 months postpartum | Attendance at clinic appointments will be collected from patient records and self-report pre- and post-natal |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Use of Condoms | 12 months postpartum | Sexual behavior (i.e., condom use) will be collected by participant self-report |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 1,967 |
Baseline characteristics
| Characteristic | Intervention Women With Partners | Total | Control Women Alone | Control Women With Partners | Intervention Women Without Partners |
|---|---|---|---|---|---|
| Age, Continuous | 30.24 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 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 577 Participants | 1967 Participants | 361 Participants | 681 Participants | 348 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Africa | 577 participants | 1967 participants | 361 participants | 681 participants | 348 participants |
| Sex: Female, Male Female | 354 Participants | 1424 Participants | 361 Participants | 361 Participants | 348 Participants |
| Sex: Female, Male Male | 223 Participants | 543 Participants | 0 Participants | 320 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 577 | 2 / 348 | 0 / 681 | 1 / 361 |
| other Total, other adverse events | 0 / 577 | 0 / 348 | 0 / 681 | 0 / 361 |
| serious Total, serious adverse events | 0 / 577 | 0 / 348 | 0 / 681 | 0 / 361 |
Outcome results
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Women With Partners | Dried Blood Spot Analysis of Medication Adherence- Mother and Infant | 56 Participants |
| Intervention Women Without Partners | Dried Blood Spot Analysis of Medication Adherence- Mother and Infant | 157 Participants |
| Control Women With Partners | Dried Blood Spot Analysis of Medication Adherence- Mother and Infant | 35 Participants |
| Control Women Alone | Dried Blood Spot Analysis of Medication Adherence- Mother and Infant | 183 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Women With Partners | Infant HIV Seroconversions | 0 Participants |
| Intervention Women Without Partners | Infant HIV Seroconversions | 4 Participants |
| Control Women With Partners | Infant HIV Seroconversions | 0 Participants |
| Control Women Alone | Infant HIV Seroconversions | 4 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Women With Partners | Attendance at Scheduled Ante and Postnatal Clinic Appointments | 99 Participants |
| Intervention Women Without Partners | Attendance at Scheduled Ante and Postnatal Clinic Appointments | 0 Participants |
| Control Women With Partners | Attendance at Scheduled Ante and Postnatal Clinic Appointments | 187 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Women With Partners | Mother Reported Rates of Infant Exclusive Breastfeeding | 102 Participants |
| Intervention Women Without Partners | Mother Reported Rates of Infant Exclusive Breastfeeding | 71 Participants |
| Control Women With Partners | Mother Reported Rates of Infant Exclusive Breastfeeding | 169 Participants |
| Control Women Alone | Mother Reported Rates of Infant Exclusive Breastfeeding | 132 Participants |
Self-reported Use of Condoms
Sexual behavior (i.e., condom use) will be collected by participant self-report
Time frame: 12 months postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Women With Partners | Self-reported Use of Condoms | 278 Participants |
| Intervention Women Without Partners | Self-reported Use of Condoms | 164 Participants |
| Control Women With Partners | Self-reported Use of Condoms | 433 Participants |
| Control Women Alone | Self-reported Use of Condoms | 185 Participants |