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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03795415
Enrollment
224
Registered
2019-01-07
Start date
2019-05-27
Completion date
2021-05-31
Last updated
2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disclosure, Empowerment, HIV/AIDS, HIV Seropositivity

Keywords

WLHIV, empowerment, disclosure, Mali

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).

Interventions

BEHAVIORALGundo So

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.

Sponsors

Fondation de France
CollaboratorOTHER
Aix Marseille Université
CollaboratorOTHER
Université du Québec a Montréal
CollaboratorOTHER
Centre Population et Développement (CEPED), Paris, France
CollaboratorUNKNOWN
ARCAD-SIDA MALI
CollaboratorOTHER
Groupe de Recherche en Psychologie Sociale (GRePS), Bron, France
CollaboratorUNKNOWN
Coalition Plus, France
CollaboratorUNKNOWN
ANRS, Emerging Infectious Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 interventionImprovement of the management of the sharing of the serological status. Empowerment in sharing the HIV status (questionnaire)
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 interventionImprovement 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 interventionImprovement 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 interventionImprovement of the management of the secret of the serological status. Empowerment in keeping secret the HIV status (questionnaire)

Secondary

MeasureTime frameDescription
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)
Changes in quality of life of WLHIV: questionnaireMeasured at the randomization and then immediately after the interventionAssess the changes in quality of life (questionnaire)
Satisfaction of the intervention: questionnaireMeasured immediately after the interventionAssess 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 interventionAssess changes of sexual practices and risk reductions strategies (questionnaire)
Reported compliance (questionnaire)Measured at the randomization and then immediately after the interventionAssess changes of reported compliance throught HIV antiretroviral treatments (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)

Countries

Mali

Contacts

Primary ContactLucas Riegel
lriegel@coalitionplus.org+33 1 77 93 97 63
Backup ContactMarie Préau, Pr
marie.preau@univ-lyon2.fr+33 4 78 77 31 63

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026