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

Conditions
HIV/AIDS
HIV Seropositivity
Disclosure
Empowerment
Interventions
Behavioral: Gundo So
Registration Number
NCT03795415
Lead Sponsor
ANRS, Emerging Infectious Diseases
Brief Summary

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

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).

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
224
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Immediate Arm (G1)Gundo So3 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.
Delayed Arm (G2)Gundo So3 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.
Primary Outcome Measures
NameTimeMethod
Short term evaluation of the burden associated with the secrecy issue using questionnairesThe 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 questionnairesThe 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 questionnairesThe 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 questionnairesThe 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)

Secondary Outcome Measures
NameTimeMethod
Changes in quality of life of WLHIV: questionnaireMeasured at the randomization and then immediately after the intervention

Assess the changes in quality of life (questionnaire)

Biological data : HIV viral loadFrom 6 months before the intervention until the last follow up (total 2 years)

Access changes in HIV viral load due to the intervention (via the medical file)

Reported compliance (questionnaire)Measured at the randomization and then immediately after the intervention

Assess changes of reported compliance throught HIV antiretroviral treatments (questionnaire)

Biological data : cluster of differentiation 4 levelsFrom 6 months before the intervention until the last follow up (total 2 years)

Access changes in cluster of differentiation 4 levels due to the intervention (via the medical file)

Satisfaction of the intervention: questionnaireMeasured immediately after the intervention

Assess the satisfaction of the intervention using questionnaire

Evolution of sexual practices and use of risk reduction strategiesMeasured at the randomization and then immediately after the intervention

Assess changes of sexual practices and risk reductions strategies (questionnaire)

Trial Locations

Locations (6)

CESAC de BAMAKO

🇲🇱

Bamako, Mali

USAC commune IV

🇲🇱

Bamako, Mali

USAC commune VI

🇲🇱

Bamako, Mali

USAC commune V

🇲🇱

Bamako, Mali

Usac Cnam

🇲🇱

Bamako, Mali

USAC commune I

🇲🇱

Bamako, Mali

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