Male Engagement in PMTCT Services
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|ClinicalTrials.gov Identifier: NCT01903889|
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : January 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|HIV||Other: clinic based intervention Other: clinic and community based intervention||Not Applicable|
This study will be conducted in Kabale District, Uganda, a rural district where prevention of mother to child transmission (PMTCT) and care and treatment (C&T) 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 C&T 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 C&T 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.
- Services statistics will be tracked to assess changes in uptake and continuation of PMTCT services.
- 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 C&T 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 C&T clients reporting consistent condom use.
- The constructive male engagement intervention will comprise both community- and clinic-based components. To assess the effectiveness of the community-based men's 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 men's workshops.
- 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 C&T clients. Specifically, interviews with C&T clients will include questions about messages communicated by providers and service delivery practices reflecting successful implementation of the intervention components.
- Finally, the study will examine the resource requirements for adding each the interventions (reinforcement of FP and male involvement) into C&T 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3806 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Promoting Constructive Male Engagement to Increase Use of Prevention of Mother to Child Transmission (PMTCT) Services|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||August 2014|
Active Comparator: Clinic based intervention
basic intervention is introduced, whereby HIV/AIDS providers are trained on contraception for HIV-positive women. They are charged with counseling C&T clients on FP; offering condoms, pills and injectables; and referring clients for other FP methods
Other: clinic based intervention
counseling C&T clients on FP; offering condoms, pills and injectables; and referring clients for other FP methods
Experimental: clinic and community based intervention
The basic intervention is introduced along with an intervention for constructive male engagement in HIV and FP services. This includes training of C&T 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.
Other: clinic and community based intervention
basic intervention is introduced along with an intervention for constructive male engagement in HIV and FP services
- To assess the effectiveness of an intervention aimed at constructively engaging men in FP decision making [ Time Frame: 12 months ]Dual method use among couples with at least one partner using C&T services
- To measure changes over time in uptake of Prong 3 PMTCT services, comparing facilities that are and are not exposed to the constructive male engagement intervention [ Time Frame: 6 months ]Number of new ANC clients
- To assess the effect of reinforcements introduced to enhance C&T providers' capacity to serve the FP needs of HIV-positive clients, as reflected in C&T clients' knowledge, attitudes, and behaviors related to FP. [ Time Frame: 12 months ]Dual method use among couples with at least one partner using C&T services 2) Knowledge and attitudes related to FP
- To explore condom use dynamics and the factors favoring and discouraging consistent use by cohabiting couples [ Time Frame: 1 month ]1) Consistency of condom use 2) Factors encouraging and impeding consistent condom use
- To evaluate men's knowledge and attitudes related to gender norms and FP and HIV services before and after participation in a 10-week community education and mobilization program. [ Time Frame: 10 months ]1) Perspectives on acceptable gender norms 2) Knowledge, attitudes, and behaviors related to use of family planning and HIV services.
- To document the technical, human, and material resources required to implement the study interventions and to estimate the financial cost of implementation at scale. [ Time Frame: 12 months ]Cost of implementing HIV-FP integration intervention and male engagement intervention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903889
|Bukinda Health Center|
|Kamkira Health Center|
|Kamwezi Health Center|
|Maziba Health Center|
|Mparo Health Center|
|Muko Health Center|
|Rubaya Health Center|
|Principal Investigator:||Theresa Hoke, Ph.D., MPH||FHI 360|