ANRS12373 GUNDO SO - Evaluation of an Empowerment Program for WLHIV in Mali

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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HIV Seropositivity, Disclosure, Empowerment, HIV/AIDS

Intervention / Treatment
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* Behavioral: Gundo So


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: having already participated in Gundo-So

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immediate Arm (G1)<br>3 months after enrollment, each big groups of 16 will be split in two groups. Women in G1 will receive the intervention Gundo-So immediately. (From month 3 to month 6). 112 women will be in immediate arm in 14 groups of 8 women. | Behavioral: Gundo So<br>* Gundo-So was adapted from a program established in quebec. It has been implemented in Mali following 3 phases: 1) cultural adaptation; 2) validation using a pre-post intervention evaluation; 3) scale-up The programm consists on 9 group meetings group spread over 9 weeks (for 8 WLHIV + 2 trained community-based leaders). Each meeting has some particular thematics with adapted tools.<br>* Other names: Gundo So - The room of confidences;|
| Delayed Arm (G2)<br>3 months after enrollment, each big groups of 16 will be split in two groups. Women in G2 will receive the intervention Gundo-So 3 months after. (From month 6 to month 9). 112 women will be in delayed arm in 14 groups of 8 women. | Behavioral: Gundo So<br>* Gundo-So was adapted from a program established in quebec. It has been implemented in Mali following 3 phases: 1) cultural adaptation; 2) validation using a pre-post intervention evaluation; 3) scale-up The programm consists on 9 group meetings group spread over 9 weeks (for 8 WLHIV + 2 trained community-based leaders). Each meeting has some particular thematics with adapted tools.<br>* Other names: Gundo So - The room of confidences;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term evaluation of the burden associated with the disclosure issue using questionnaires | Improvement of the management of the sharing of the serological status. Empowerment in sharing the HIV status (questionnaire) | 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 | 
| Short term evaluation of the burden associated with the secrecy issue using questionnaires | Improvement of the management of the secret of the serological status. Empowerment in keeping secret the HIV status (questionnaire) | 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 | 
| Mid term evaluation of the burden associated with the disclosure issue using questionnaires | Improvement of the management of the sharing of the serological status. Empowerment in sharing the HIV status (questionnaire) | The mid term effect will be measured 9 months after the intervention : up to 9 months after the intervention | 
| Mid term evaluation of the burden associated with the secrecy issue using questionnaires | Improvement of the management of the secret of the serological status. Empowerment in keeping secret the HIV status (questionnaire) | The mid term effect will be measured 9 months after the intervention : up to 9 months after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in quality of life of WLHIV: questionnaire | Assess the changes in quality of life (questionnaire) | Measured at the randomization and then immediately after the intervention | 
| Evolution of sexual practices and use of risk reduction strategies | Assess changes of sexual practices and risk reductions strategies (questionnaire) | Measured at the randomization and then immediately after the intervention | 
| Reported compliance (questionnaire) | Assess changes of reported compliance throught HIV antiretroviral treatments (questionnaire) | Measured at the randomization and then immediately after the intervention | 
| Biological data : HIV viral load | Access changes in HIV viral load due to the intervention (via the medical file) | From 6 months before the intervention until the last follow up (total 2 years) | 
| Biological data : cluster of differentiation 4 levels | Access changes in cluster of differentiation 4 levels due to the intervention (via the medical file) | From 6 months before the intervention until the last follow up (total 2 years) | 
| Satisfaction of the intervention: questionnaire | Assess the satisfaction of the intervention using questionnaire | Measured immediately after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WLHIV, empowerment, disclosure, Mali