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临床试验/NCT03795415
NCT03795415Unknown不适用

Evaluation of the Short- and Mid-term Effects of an Empowerment Program Focused on Serostatus Disclosure Management for Women Living With HIV in Mali

ANRS, Emerging Infectious Diseases6 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2019年5月27日最近更新:
适应症

试验速览

阶段
不适用
入组人数
224
试验地点
6
主要终点
Short term evaluation of the burden associated with the secrecy issue using questionnaires

研究概览

简要总结

The objective of this research is to measure the short- and mid-term effects of an empowerment program focused on serostatus disclosure management for women living with HIV (WLHIV) in Mali on the "burden of secrecy".

详细描述

Serostatus disclosure is a critical issue for persons living with HIV (PLHIV). Studies identified numerous benefits associated with disclosure, but various negative consequences have also been documented. Gender inequality must be taken into account regarding the disclosure issue, in particular in Mali, where women are economically dependent and have a low decision-making power. Moreover, in Mali, since 2006, PLHIV have a legal obligation to disclose their serostatus to their spouse and sexual partner(s) " as soon as possible, or within 6 weeks " after the diagnosis. Although this law is not enforced, it highlights the sensitive nature of the serostatus disclosure issue and raise concerns among PLHIV and other stakeholders.

To support women living with HIV (WLHIV), an empowerment program (Gundo-So) was implemented by ARCAD-SIDA in Mali, in collaboration with several partners. This program aims to empower WLHIV, so that they can make informed decision about disclosing or keeping their serostatus secret in their various life contexts, and that they can identify strategies to disclose or to keep the secret, as well as to manage potential negative reactions. Gundo-So ("The room of confidences") was adapted from a program established in quebec and has been implemented in Mali.

The objective of this research is to measure the short- and mid-term effects of an empowerment program focused on serostatus disclosure management for women living with HIV (WLHIV) in Mali on the "burden of secrecy".

The evaluation of the effects of the Gundo-So program will be helpful to assess the relevance of a national or subregional extension of the program, or even an adaptation to other target populations (e.g. heterosexual men and men who have sex with men living with HIV).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • women living with HIV
  • living in Bamako area (Mali)
  • over 18 years old
  • knowing their serological status for more than 6 months and less than 5 years
  • being available to participate in the 9 weekly sessions lasting about 2 hours each.

排除标准

  • having already participated in Gundo-So

结局指标

主要结局

Short term evaluation of the burden associated with the secrecy issue using questionnaires

时间窗: The short term effect will be measured at the end of the intervention and compared between Group 1 and 2. Up to 6 months from the beginning of the randomization to the end of the intervention

Improvement of the management of the secret of the serological status. Empowerment in keeping secret the HIV status (questionnaire)

Mid term evaluation of the burden associated with the disclosure issue using questionnaires

时间窗: The mid term effect will be measured 9 months after the intervention : up to 9 months after the intervention

Improvement of the management of the sharing of the serological status. Empowerment in sharing the HIV status (questionnaire)

Mid term evaluation of the burden associated with the secrecy issue using questionnaires

时间窗: The mid term effect will be measured 9 months after the intervention : up to 9 months after the intervention

Improvement of the management of the secret of the serological status. Empowerment in keeping secret the HIV status (questionnaire)

Short term evaluation of the burden associated with the disclosure issue using questionnaires

时间窗: The short term effect will be measured at the end of the intervention and compared between Group 1 and 2. Up to 6 months from the beginning of the randomization to the end of the intervention

Improvement of the management of the sharing of the serological status. Empowerment in sharing the HIV status (questionnaire)

次要结局

  • Changes in quality of life of WLHIV: questionnaire(Measured at the randomization and then immediately after the intervention)
  • Biological data : HIV viral load(From 6 months before the intervention until the last follow up (total 2 years))
  • Reported compliance (questionnaire)(Measured at the randomization and then immediately after the intervention)
  • Biological data : cluster of differentiation 4 levels(From 6 months before the intervention until the last follow up (total 2 years))
  • Satisfaction of the intervention: questionnaire(Measured immediately after the intervention)
  • Evolution of sexual practices and use of risk reduction strategies(Measured at the randomization and then immediately after the intervention)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (6)

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