跳至主要内容
临床试验/NCT04356157
NCT04356157Unknown不适用

WeMen! Improving Women's Access to Healthcare System Through Men's Inclusion

University of Rome Tor Vergata4 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
450
试验地点
4
主要终点
Retention in care and adherence to treatment

研究概览

简要总结

Background: More than two-thirds of people living with HIV live in Sub-Saharan Africa, where the HIV prevalence in the adult population (aged 15-49) is 3.9%.

In these countries a critical issue is represented by low level of adherence to treatment particularly in HIV positive pregnant women. Among the causes, the lack of male partner involvement represents a significant criticality. This issue emerge in Malawi, one of the countries with the highest prevalence of HIV in the world: 9.2% of the adult population living with HIV in 2018.

Objective: to assess three different interventions aimed at improving adherence and retention to Anti Retroviral therapy among HIV positive women through engagement with their life partner in four Malawian healthcare centres.

Methods: The prospective, controlled before-and-after study is articulated in three phases (total 24 months): pre-intervention, intervention and post-intervention analyses. The number of selected clinical centres is limited to four, one for each intervention plus a centre where no intervention will be performed (control arm). The interventions are 1) opening the facility on Saturday a month, only for men, defined "special day"; 2) peer-to-peer counselling among men, "male champions"; 3) providing incentive to all women accompanied by their partners at the facility, "nudge" (note1).

The primary outcome of the study is the evaluation of the variations in retention in care and women's adherence to therapeutic protocols; the intermediate outcome is the assessment of the variations in Male Involvement (MI).

The level of MI in the health of female partners (intermediate outcome) will be evaluated through a questionnaire administered at baseline and in the post-intervention phase. Data will be collected at the clinical centres and will be stored in two electronic databases.

Results: Analysis of data collected in the four centres during the pre-intervention phase is on-going as the enrolment is stopped 31st March 2020. Total patients enrolled are 452 (133 Namandanje: 133, Kapeni: 78, Kapire: 75, Balaka: 166). Meantime, several meetings are performed in the centres to organize the intervention phase.

Conclusions: The study will identified the better intervention to involve male partners in women's health according to an approach based on a broad spectrum of behaviours.

  • Note1: the reason of the incentive is not reward the participation in the study but is the main activity of the intervention assessed. The intervention consist in giving an incentive. For this reason is not recommendable to eliminate this information as requested by the reviewer.

详细描述

The design is a prospective controlled study, that is suitable for the evaluation of promising interventions to improve male involvement and enhance maternal adherence to HIV PMTCT.

For this study, we adopted a framework based on the ecological model adapted by Kaufman et al to health behaviors in HIV prevention.

According to the ecological model, many factors affect male involvement in women's health care processes at different levels. In this study, we focused on individual level, interpersonal and network (eg, family and peers), community, health system (health facility level), and structural level (eg, access to transportation).

The aim of the study is to evaluate 3 different interventions aimed at improving adherence and retention to Anti Retroviral therapy among HIV-positive women through engagement with their life partner. The interventions are (1) testing peer-to-peer counseling and community-level health education sessions delivered by men, male champions; (2) opening the facility once a month, only for men, special day; and (3) providing incentive to all women accompanied by their partners at the facility, nudge or incentive (note1).

  • Intervention 1 (Male Champions) will act at the community level, providing educational interventions that are aimed at territorial communities and religious groups.
  • Intervention 2 (Special Day) will act at the health system level delivering activities based on health facilities that are aimed at reshaping the clinic as male-friendly.
  • Intervention 3 will also act at the structural level by providing incentives to support the cost of transportation and other costs that reduce a male partner's ability to access the service (note1).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Being HIV positive
  • Inclusion in an HIV/AIDS prevention and treatment program
  • Age of 18 years or older
  • Living at home with a male partner

排除标准

  • No HIV positive
  • No included in a HIV/AIDS prevention and treatment program
  • Under 18 years old
  • No partner living at home

结局指标

主要结局

Retention in care and adherence to treatment

时间窗: 2 years

Retention in care will be measured as the cumulative proportion of dropouts from the treatment program at 6 months, 1 year, and 2 years (excluding patients transferred to another centre or those who died). Adherence will be measured through the following indicators: (1) The cumulative proportion of medical appointments missed in a month period in the centre; (2) the cumulative proportion of appointments for drug delivery missed in a month period in the centre; (3) the cumulative proportion of women who suppressed viral load; (4) the cumulative proportion of women with a suppressed viral load that have a re-bound in viremia.

次要结局

  • Male Involvement 2 - Proportion of men accepting HIV testing and counselling(2 years)
  • Male Involvement - Proportion of women accompanied by partners(2 years)
  • Male Involvement 4 - Score scale of Gender Based Violence reported from female partner(2 years)
  • Male Involvement 3 - Score scale of MI in health practices reported from female partners(2 years)

研究者

发起方
University of Rome Tor Vergata
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leonardo Palombi

Full Professor

University of Rome Tor Vergata

研究点 (4)

Loading locations...

相似试验