Male Engagement in PMTCT Services
Condition: HIV
Study type: Interventional

Summary: 
      The study employs a quasi-experimental design in 8 public health centers in southwest Uganda
      offering care and treatment (C&T) services. In 4 health centers, a 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. 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 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.
    

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 (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.

        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 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.

        3. 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.

        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 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.

        5. 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.
    

Intervention name(s): clinic based intervention; clinic and community based intervention
Intervention type(s): Other; Other
Intervention description(s): counseling C&T clients on FP; offering condoms, pills and injectables; and referring clients for other FP methods; basic intervention is introduced along with an intervention for constructive male engagement in HIV and FP services
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: AE adverse event; AIDS acquired immunodeficiency syndrome; ALT (SGPT) alanine aminotransferase; ART antiretroviral therapy; AST (SGOT) aspartate aminotransferase; DCF data collection forms; DMC Data Monitoring Committee; FDA (U.S.) Food and Drug Administration; GCP Good Clinical Practice guidelines; HB sAg Hepatitis B surface antigen; ICH International Conference of Harmonization; IND Investigational New Drug Application; IRB Institutional Review Board; IU International units; mg milligram(s); mm3 cubic millimeter(s); PCR polymerase chain reaction; SAE serious adverse event; µg microgram; ULN upper limit of the normal range; WB Western Blot; ANC Antenatal care; ARV Antiretroviral; C&T Care and treatment; CPR Contraceptive prevalence rate; DHS Demographic and Health Survey; EGPAF Elizabeth Glaser Pediatric AIDS Foundation; FP Family planning; HIV Human immunodeficiency virus; HTC HIV testing and counseling; IUCD Intrauterine contraceptive device; MCH Maternal/child health; PDA Personal digital assistant; PEPFAR President's Emergency Plan for AIDS Relief; PHSC Protection of Human Subjects Committee; PMTCT Prevention of maternal to child transmission; STAR-SW Strengthening TB and HIV/AIDS Response in the South Western Region of Uganda; STI Sexually transmitted infection; TM Technical monitor; USAID United States Agency for International Development; WHO World Health Organization