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A counseling intervention to address HIV stigma at entry into antenatal care in Tanzania (Maisha): study protocol for a pilot randomized controlled trial.

ABSTRACT: BACKGROUND:HIV-related stigma significantly impacts HIV care engagement, including in prevention of mother-to-child transmission of HIV (PMTCT) programs. Maisha is a stigma-based counseling intervention delivered during the first antenatal care (ANC) visit, complementing routine HIV counseling and testing. The goal of Maisha is to promote readiness to initiate and sustain treatment among those who are HIV-positive, and to reduce HIV stigmatizing attitudes among those who test negative. METHODS:A pilot randomized control trial will assess the feasibility and acceptability of delivering Maisha in a clinical setting, and the potential efficacy of the intervention on HIV care engagement outcomes (for HIV-positive participants) and HIV stigma constructs (for all participants). A total of 1000 women and approximately 700 male partners will be recruited from two study clinics in the Moshi municipality of Tanzania. Participants will be enrolled at their first ANC visit, prior to HIV testing. It is estimated that 50 women (5%) will be identified as HIV-positive. Following consent and a baseline survey, participants will be randomly assigned to either the control (standard of care) or the Maisha intervention. The Maisha intervention includes a video and counseling session prior to HIV testing, and two additional counseling sessions if the participant tests positive for HIV or has an established HIV diagnosis. A subset of approximately 500 enrolled participants (all HIV-positive participants, and a random selection of HIV-negative participants who have elevated stigma attitude scores) will complete a follow-up assessment at 3?months. Measures will include health outcomes (care engagement, antiretroviral adherence, depression) and HIV stigma outcomes. Quality assurance data will be collected and the feasibility and acceptability of the intervention will be described. Statistical analysis will examine potential differences between conditions in health outcomes and stigma measures, stratified by HIV status. DISCUSSION:ANC provides a unique and important entry point to address HIV stigma. Interventions are needed to improve retention in PMTCT care and to improve community attitudes toward people living with HIV. Results of the Maisha pilot trial will be used to generate parameter estimates and potential ranges of values to estimate power for a full cluster-randomized trial in PMTCT settings, with extended follow-up and enhanced adherence measurement using a biomarker. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03600142. Registered on 25 July 2018.

SUBMITTER: Watt MH

PROVIDER: S-EPMC6937735 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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A counseling intervention to address HIV stigma at entry into antenatal care in Tanzania (Maisha): study protocol for a pilot randomized controlled trial.

Watt Melissa H MH Knippler Elizabeth T ET Minja Linda L Kisigo Godfrey G Knettel Brandon A BA Ngocho James S JS Renju Jenny J Osaki Haika H Mwamba Rimel R Rogathi Jane J JJ Mmbaga Blandina T BT

Trials 20191230 1

<h4>Background</h4>HIV-related stigma significantly impacts HIV care engagement, including in prevention of mother-to-child transmission of HIV (PMTCT) programs. Maisha is a stigma-based counseling intervention delivered during the first antenatal care (ANC) visit, complementing routine HIV counseling and testing. The goal of Maisha is to promote readiness to initiate and sustain treatment among those who are HIV-positive, and to reduce HIV stigmatizing attitudes among those who test negative.<h ...[more]

PMID: 31888700

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Project description:In a context of high rates of HIV prevalence, concerns over hormonal contraceptive use and the potential for increased risk of HIV acquisition have led to increased attention to counseling messages, particularly for users of the injectable. However, the consequence of adding additional HIV risk messages to family planning counseling sessions was not well understood. This evaluation assessed the effect of providing revised injectable and HIV risk counseling messages on contraceptive knowledge and behavior during a three month pilot intervention. The pilot intervention was conducted September-November 2018 with all eligible family planning clients in ten healthcare facilities located in the Iringa and Njombe regions of Tanzania. Data collection for the evaluation occurred November-December 2018 and included 471 client exit interviews, 26 healthcare provider interviews, and the extraction of service statistics for 12 months prior to the intervention and three months of the intervention. Univariate and bivariate analyses were used to assess quantitative interview data. Thematic qualitative assessment was used to assess qualitative interview data from healthcare providers. Interrupted time series analysis was used to assess changes in the trend of contraceptive uptake. Results indicate that the counseling messages did not cause a decrease in the uptake of injectables (Depo-Provera): 97 percent of interviewed clients received Depo-Provera at their visit; sixty percent reported an intention to use condoms for dual protection. The analysis of service statistics showed no statistical difference in the trend of Depo-Provera uptake between the pre-intervention and intervention periods (p = 0.116). Overall knowledge of counseling messages by clients was good; however only 64.8% of women correctly responded that women at risk of getting HIV can use any method of family planning. Providers' knowledge of the messages was high, though it appears that not all messages were consistently provided during the counseling sessions. The findings from this evaluation provide evidence that complex HIV counseling messages can be implemented in family planning programs in Tanzania, and potentially in other countries that are considering how to better integrate HIV risk messages into family planning counseling.

Project description:BackgroundSub-Saharan Africa (SSA) is heavily burdened by HIV, with 85% of the global new infections among adolescents happening in the region. With advances in medication and national policies promoting antiretroviral therapy (ART), children < 15 years living with HIV (CLWH) continue to grow with a chronic, highly stigmatized disease. Unfortunately, the stigma they experience results in much lower quality of life, including poor mental health and treatment outcomes. Family members also experience stigma and shame by virtue of their association with an HIV-infected family member. Yet, stigma-reduction interventions targeting CLWH and their families are very limited. The goal of this study is to address HIV-associated stigma among CLWH and their caregivers in Uganda.MethodsThis three-arm cluster randomized control trial, known as Suubi4Stigma, will evaluate the feasibility, acceptability, and preliminary impact of two evidence-based interventions: (1) group cognitive behavioral therapy (G-CBT) focused on cognitive restructuring and strengthening coping skills at the individual level and (2) a multiple family group (MFG) intervention that strengthens family relationships to address stigma among CLWH (N = 90, 10-14 years) and their families (dyads) in Uganda. Nine clinics will be randomized to one of three study arms (n = 3 clinics, 30 child-caregiver dyads each): (1) usual care; (2) G-CBT + usual care; and (3) MFG + usual care. Both treatment and control conditions will be delivered over a 3-month period. Data will be collected at baseline (pre-intervention) and at 3 months and 6 months post-intervention initiation.ConclusionThe primary aim of the proposed project is to address the urgent need for theoretically and empirically informed interventions that seek to reduce HIV-associated stigma and its negative impact on adolescent health and psychosocial well-being. As several countries in SSA grapple with care and support for CLWH, this study will lay the foundation for a larger intervention study investigating how HIV-associated stigma can be reduced to foster healthy child development-especially for CLWH as they transition through adolescence.Trial registrationClinicalTrials.gov: NCT04528732 ; Registered August 27, 2020.

Project description:Intimate partner violence (IPV) affects over one-in-four women globally. Combined economic and social empowerment interventions are a promising IPV prevention model. However, questions remain on the mechanisms through which such interventions prevent IPV, and whether standalone social empowerment interventions can work in the absence of an economic component. This secondary analysis of MAISHA Study data (north-western Tanzania) explores pathways through which a group-based gender-training intervention, delivered to women standalone or alongside microfinance, may impact on physical IPV risk. Two cluster-randomised trials (CRT) assessed the impact of the MAISHA intervention on women's IPV risk; CRT01 among women in 66 pre-existing microfinance groups (n = 919), and CRT02 among 66 newly-formed groups not receiving microfinance (n = 1125). Women were surveyed at baseline and 29 months follow-up. Sub-group analyses explored whether intervention effects on past-year experience of physical IPV varied by participant characteristics. Mediators of intervention effect on physical IPV were explored using mixed-effects logistic regression (disaggregated by trial). In CRT01, MAISHA was associated with reduced past-year physical IPV (adjusted-OR 0.63, 95%CI 0.41-0.98), with stronger effects among those younger, more financially independent, and without prior physical IPV. CRT02 showed no impact on physical IPV, overall or among sub-groups. In CRT01, individual-level reduced acceptability of IPV and group-level confidence to intervene against IPV emerged as potential mediators of intervention effect, while relationship-level indicators of communication were not impacted. In CRT02, positive impacts on individual-level attitudes did not translate into reduced IPV risk. In CRT02, arguments with partners over perceived transgressions of gender roles increased in the intervention-arm. Neither trial resulted in increased separations. Findings illustrate the importance of addressing poverty and women's economic dependence on men, structural factors that may impede the success of socially oriented violence prevention programming. Programming with men is also crucial to ameliorate risks of backlash against attitudinal/behavioural change among women. Trial registration: ClinicalTrials.gov #NCT02592252.

Project description:Background: Substance use and mental health are two barriers to engagement in care and antiretroviral therapy (ART) adherence among youth and young adults living with HIV (YLWH). The consequences of suboptimal adherence in YLWH are increased risk of HIV transmission and a future generation of immunodeficient adults with drug-resistant virus. Methods: The Youth to Telehealth and Texting for Engagement in Care (Y2TEC) study was a pilot randomized crossover trial that examined the feasibility and acceptability of a novel video-counseling series and accompanying text messages aimed at mental health, substance use, and HIV care engagement for YLWH. The intervention consisted of twelve 20-30-min weekly video-counseling sessions focused on identifying and addressing barriers to HIV care, mental health, and substance use challenges. Participants completed quantitative surveys at baseline, 4 months, and 8 months. Feasibility and acceptability were evaluated using prespecified benchmarks. Results: Fifty YLWH aged 18-29 years living in the San Francisco Bay Area were enrolled. Eighty-six percent and 75% of participants were retained at 4 and 8 months, respectively. A total of 455 (76%) video-counseling sessions were completed. In 82% of sessions, participants responded that they strongly agreed/agreed with this statement: "I felt heard, understood, and respected by the counselor." In 81% of sessions, participants responded that they strongly agreed/agreed with this statement: "Overall, today's session was right for me." At baseline, among participants reporting mental health challenges, only 10% noted having ever received mental health services, and among those who reported substance use challenges, ∼19% reported ever receiving substance use services. After 4 months of the Y2TEC intervention, participants reported slightly higher ART adherence and HIV knowledge, decreased depression and anxiety, and reduced stigma related to mental health and substance use. Conclusions: The Y2TEC intervention using video-counseling and text messaging was feasible and acceptable for YLWH. ClinicalTrials.gov ID: NCT03681145.

Project description:BACKGROUND:Overweight and obesity are America's number one health concern. The prevalence of obesity in the United States is greater than 36%, a rate that has doubled since 1970. As the second most preventable cause of death, obesity is a risk factor for diabetes, cardiovascular disease, stroke, and cancer, all major causes of death. Primary care clinics may be an ideal setting for weight control interventions to help manage and prevent diabetes. For this reason, the Centers for Medicare and Medicaid Services (CMS) implemented a health care procedure coding system code for intensive behavioral therapy (IBT) for obesity within primary care in 2012 to facilitate payment for addressing obesity, which was followed by broader coverage by most insurers for IBT for adults in 2013. However, the impact of this coverage on patient-centered outcomes is largely unknown. OBJECTIVE:The overarching goal of this study is to understand the comparative effectiveness of obesity counseling as covered by CMS and other insurers in improving weight loss for adults either with or at increased risk for type 2 diabetes. METHODS:This study leverages the novel infrastructure of the Patient-Centered Outcomes Research Institute-funded PaTH Clinical Data Research Network. The PaTH network is comprised of Geisinger Health System, Johns Hopkins University, Johns Hopkins Health System, Lewis Katz School of Medicine at Temple University, Temple Health System, Penn State College of Medicine, Penn State Milton S Hershey Medical Center, University of Pittsburgh, UPMC and UPMC Health Plan, and the University of Utah. Electronic health record (EHR) data will originate from the 6 PaTH health systems. Specifically, we will (1) evaluate the impact of broader preventive service coverage for obesity screening and counseling on weight loss, diabetes incidence, and diabetes outcomes in patients with diabetes or at increased risk for diabetes (defined by body mass index [BMI] ?25). We will determine how the annual probability of receiving obesity and/or nutritional counseling changed pre- and postpolicy across all insurers in a cohort of patients with diabetes and at high risk for diabetes. We will (2) compare patient weight loss and diabetes-related outcomes among those who receive obesity screening and counseling with those who do not, following implementation of preventive service coverage. We will examine postpolicy impact of obesity screening and counseling in a cohort of patients with diabetes and at increased risk for diabetes. Specific outcomes to be examined include weight loss, diabetes incidence, and diabetes outcomes. Exploratory outcomes will include patient-reported outcomes. Furthermore, we will determine patient characteristics, including demographics, and practice characteristics, including provider type. RESULTS:Our PCORI-funded study is underway. To date, we have obtained our second data extraction from the PaTH CDRN and are performing data editing and cleaning. Next steps include analysis of early policy change. CONCLUSIONS:Given patients who are overweight are at highest risk for diabetes, improved weight management services could prevent diabetes and its negative health outcomes. Comparing weight and diabetes outcomes in 3 states using EHRs and claims data before and after this policy was implemented using the PaTH Network will allow important insight into policy effectiveness. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/12054.

Dataset Information

A counseling intervention to address HIV stigma at entry into antenatal care in Tanzania (Maisha): study protocol for a pilot randomized controlled trial.

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A counseling intervention to address HIV stigma at entry into antenatal care in Tanzania (Maisha): study protocol for a pilot randomized controlled trial.

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