Ignite Creation Date:
2024-05-06 @ 2:37 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02085356
Status:
COMPLETED
Last Update Posted:
2019-02-21
First Post:
2014-03-10
Brief Title:
Implementing a Comprehensive Prevention of Mother-to-Child Transmission of HIV Program for South African Couples
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Implementing Comprehensive PMTCT and HIV Prevention for South African Couples
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 wivespartners 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 367 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-reducingPMTCT promotion intervention addressing the barriers to PMTCT eg 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
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 367 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-reducingPMTCT promotion intervention addressing the barriers to PMTCT eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HD078187 | NIH | None | httpsreporternihgovquickSearch1R01HD078187 |