A Gender Transformative Implementation Strategy With Providers to Improve HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 382
- 试验地点
- 2
- 主要终点
- Change in Clinic Visit Adherence From Baseline Among Patients (Retention in Care)
研究概览
简要总结
Gender norms embedded in the health-system and broader community shape patient-provider relationships in ways that may undermine the provision of antiretroviral treatment (ART) counseling for men and women in Uganda. This study seeks to develop and evaluate the acceptability, feasibility, and preliminary efficacy of an innovative gender transformative implementation strategy to improve HIV provider capacity for equitable HIV care and ART adherence counseling.
详细描述
Antiretroviral treatment (ART) is the single most effective clinical intervention in the fight against HIV. However, in Uganda only 56% of people living with HIV were virally suppressed in 2017 with significant disparities between men and women, suggesting problems with implementation. While gender norms are a known driver of HIV disparities in sub-Saharan Africa, and patient-provider relationships are a key factor in HIV care engagement, little research has focused on the role that gender norms have in shaping the equitable provision of treatment and quality of ART counseling. The overall research objective is to develop and pilot test an implementation strategy to increase providers' capacity to provide equitable and gender-tailored treatment and counseling to HIV-infected men and women.
Delivered to HIV providers, this group training integrates a gender transformative approach with adapted evidence-based strategies to reduce biases and increase gender equitable attitudes. The pilot trial will assess the implementation strategy's effectiveness by comparing changes in provider (competence for gender sensitive care) and in patient outcomes (clinic attendance, ART adherence, viral load) between the training intervention and usual care through 12-months.
The implementation strategy will be assessed through a quasi-experimental pre/post design. Clinics will be randomly assigned to either the intervention or control condition. Providers in the intervention condition will receive a series of group training sessions. All participants in the provider cohort will complete interviewer administered questionnaires at baseline, 6-, and 12- month follow-up. In addition to the assessment of the cohort of HIV providers, the study will obtain additional data on the impact of the provider training on patient outcomes. Patient participants will complete an interviewer administered questionnaire at baseline, 6-, and 12- month follow-up, and will provide permission for the study team to review and extract relevant data from their clinic records related to engagement in HIV care. The total N and primary outcomes reflected in the clinicaltrials.gov database reflects the patient cohort (N=240, 120 per treatment arm). Secondary outcomes are obtained from the provider cohort (n=20-35 providers per clinic).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV care provider at the selected clinics, including HIV medical and clinical officers, nurses, midwives, linkage facilitators, counselors.
- •18 years of age or older
- •Fluent in English or Luganda
- •Patient Cohort:
- •Inclusion Criteria:
- •HIV-infected
- •Enrolled in care at the clinic of recruitment
- •pre-ART (newly diagnosed) or newly initiated on ART (within 3 months-1 year) or struggling with treatment adherence, defined in two ways: (1) most recent viral load results unsuppressed as assessed through clinic records; (2) or self-reported non-adherence as by the Adult AIDS Clinical Trials Group (AACTG) scale 4-day adherence recall questions. This scale has demonstrated good construct validity in Uganda and strong correlations with viral load;
- •18 years of age or an emancipated minor
- •Fluent in Luganda or English
排除标准
- 未提供
结局指标
主要结局
Change in Clinic Visit Adherence From Baseline Among Patients (Retention in Care)
时间窗: Baseline, 6-months, and 12-months
Proportion of kept visits/scheduled visits (kept + missed visits) (continuous measure, range =0.0-1.0)
Change in Proportion of Missed Antiretroviral (ARV) Doses From Baseline Among Clients
时间窗: Baseline, 6-months, and 12-months
AACTG Adherence Instruments, self-reported questionnaire on medication adherence from the Adult AIDS Clinical Trials Group (AACTG); operationalized as a proportion of total missed doses (missed doses/total doses) (continuous measure, range =0.0-1.0)
Change in Competence for Gender-sensitive Care From Baseline Among Providers
时间窗: Baseline, 6-months, and 12-months
Adapted from the Nijmegen Gender Awareness in Medicine Scale (N-GAMS); collected from provider cohort; 9 items, total possible score using mean scoring: 1-5 (high score = better outcome)
次要结局
- Change in Self-efficacy for Client-centered Communication From Baseline Among Providers(Baseline, 6-months, and 12-months)
- Change in Empathy Towards Clients From Baseline Among Providers(Baseline, 6-months, and 12-months)
- Change in the Use of Emotional Regulation and Stress Reduction Techniques From Baseline Among Providers(Baseline, 6-months, and 12-months)
- Change in Perceived Quality of Communication From HIV Providers From Baseline Among Clients(Baseline, 6-months, and 12-months)
- Change in Perceived Level of Participatory Decision-making Related to HIV Care From Baseline Among Clients(Baseline, 6-months, and 12-months)
- Change in Satisfaction With HIV Care From Baseline Among Clients(Baseline, 6-months, and 12-months)
- Change in Total HIV Stigma Score Among Clients(Baseline, 6-months, and 12-months)
- Change in Anticipated HIV Stigma Among Clients(Baseline, 6-months, and 12-months)
- Change in Enacted HIV Stigma Among Clients(Baseline, 6-months, and 12-months)
- Change in Internalized HIV Stigma Among Clients(Baseline, 6-months, and 12-months)