Ignite Creation Date:
2024-05-06 @ 1:48 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01903889
Status:
COMPLETED
Last Update Posted:
2015-01-09
First Post:
2013-07-17
Brief Title:
Male Engagement in PMTCT Services
Sponsor:
FHI 360
Organization:
FHI 360
Study Overview
Official Title:
Promoting Constructive Male Engagement to Increase Use of Prevention of Mother to Child Transmission PMTCT Services
Status:
COMPLETED
Status Verified Date:
2015-01
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:
The study employs a quasi-experimental design in 8 public health centers in southwest Uganda offering care and treatment CT services In 4 health centers a basic intervention is introduced whereby HIVAIDS providers are trained on contraception for HIV-positive women They are charged with counseling CT clients on FP offering condoms pills and injectables and referring clients for other FP methods In the other 4 health centers the basic intervention is introduced along with an intervention for constructive male engagement in HIV and FP services This includes training of CT providers on gender-based influences on health behaviors provision of couples HIV testing and FP counseling services and community-based education for men to promote gender equitable norms and male participation in health services
Detailed Description:
This study will be conducted in Kabale District Uganda a rural district where prevention of mother to child transmission PMTCT and care and treatment CT services are offered in eight public sector health facilities The primary aim of this study is to test an intervention for increasing use of the full spectrum of PMTCT services including family planning FP through enhanced constructive male involvement in reproductive health decision making This aim will be accomplished by conducting a cluster randomized trial whereby a constructive male engagement intervention package will be introduced in four randomly selected health centers and surrounding communities the other four sites will serve as comparisons Pre- and post-intervention cross sectional surveys will be conducted with male and female CT clients to assess intervention effectiveness measured in terms of dual method use In addition to the male engagement intervention reinforcements will be introduced in all eight participating facilities to enhance providers capacity to serve the FP needs of CT clients We hypothesize that the percentage of clients reporting dual method use will increase slightly in all facilities as a result of this HIV-FP integration intervention To measure the independent effect of the reinforcements the study will compare contraceptive knowledge attitudes and behaviors of clients measured pre- and post-intervention in the comparison sites only in the absence of the male engagement intervention We further hypothesize that improvements will be incrementally greater in the four facilities exposed to the additional constructive male engagement intervention
The study will include additional data collection and analyses to support secondary objectives
1 Services statistics will be tracked to assess changes in uptake and continuation of PMTCT services
2 The study will include a qualitative component to investigate condom use behaviors Based on other investigations it is anticipated that rates of self-reported condom use among CT clients will be high To examine those behaviors more closely and to circumvent courtesy bias often associated with quantitative surveys the study will conduct individual in-depth interviews with a subset of female and male CT clients reporting consistent condom use
3 The constructive male engagement intervention will comprise both community- and clinic-based components To assess the effectiveness of the community-based mens workshops the study will assess changes in knowledge attitudes and behaviors among men exposed to the community-based intervention by surveying them before and 4 months after community-level training is held Interviews will assess knowledge and attitudes related to FP and HIV services PMTCT in particular with particular focus on gender norms supporting constructive male involvement Interviews will also examine clients recollection of services and messages received in the health center along with their direct and indirect exposure to the community-based mens workshops
4 The effectiveness of the intervention components aimed at reinforcing the capacity of clinic-based providers to serve the family planning needs of HIV-positive individuals and to engage male partners constructively in FP decision making will be assessed in terms of its impact on CT clients Specifically interviews with CT clients will include questions about messages communicated by providers and service delivery practices reflecting successful implementation of the intervention components
5 Finally the study will examine the resource requirements for adding each the interventions reinforcement of FP and male involvement into CT services Based on costs of the piloted interventions the study will arrive at an estimate of the cost of implementing these interventions at scale under the direction of the district management team
The study will include additional data collection and analyses to support secondary objectives
1 Services statistics will be tracked to assess changes in uptake and continuation of PMTCT services
2 The study will include a qualitative component to investigate condom use behaviors Based on other investigations it is anticipated that rates of self-reported condom use among CT clients will be high To examine those behaviors more closely and to circumvent courtesy bias often associated with quantitative surveys the study will conduct individual in-depth interviews with a subset of female and male CT clients reporting consistent condom use
3 The constructive male engagement intervention will comprise both community- and clinic-based components To assess the effectiveness of the community-based mens workshops the study will assess changes in knowledge attitudes and behaviors among men exposed to the community-based intervention by surveying them before and 4 months after community-level training is held Interviews will assess knowledge and attitudes related to FP and HIV services PMTCT in particular with particular focus on gender norms supporting constructive male involvement Interviews will also examine clients recollection of services and messages received in the health center along with their direct and indirect exposure to the community-based mens workshops
4 The effectiveness of the intervention components aimed at reinforcing the capacity of clinic-based providers to serve the family planning needs of HIV-positive individuals and to engage male partners constructively in FP decision making will be assessed in terms of its impact on CT clients Specifically interviews with CT clients will include questions about messages communicated by providers and service delivery practices reflecting successful implementation of the intervention components
5 Finally the study will examine the resource requirements for adding each the interventions reinforcement of FP and male involvement into CT services Based on costs of the piloted interventions the study will arrive at an estimate of the cost of implementing these interventions at scale under the direction of the district management team
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