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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03795415
• Other study ID #: ANRS12373
• Status: Recruiting
• Start date: May 27, 2019
• Est. completion date: May 2021

Study information

• Verified date: July 2019
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: Lucas Riegel
• Phone: +33 1 77 93 97 63
• Email: lriegel[@]coalitionplus.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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".

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 information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: May 2021
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disclosure
• Empowerment
• HIV Seropositivity
• HIV/AIDS

Intervention

Behavioral:
• Gundo 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.

Locations

Country	Name	City	State
Mali	CESAC de BAMAKO	Bamako
Mali	Usac Cnam	Bamako
Mali	USAC commune I	Bamako
Mali	USAC commune IV	Bamako
Mali	USAC commune V	Bamako
Mali	USAC commune VI	Bamako

Sponsors (8)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Aix Marseille Université, ARCAD-SIDA MALI, Centre Population et Développement (CEPED), Paris, France, Coalition Plus, France, Fondation de France, Groupe de Recherche en Psychologie Sociale (GRePS), Bron, France, Universite du Quebec a Montreal

Country where clinical trial is conducted

Mali, 

References & Publications (1)

Bernier A, Yattassaye A, Beaulieu-Prévost D, Otis J, Henry E, Flores-Aranda J, Massie L, Préau M, Keita BD. Empowering Malian women living with HIV regarding serostatus disclosure management: Short-term effects of a community-based intervention. Patient Educ Couns. 2018 Feb;101(2):248-255. doi: 10.1016/j.pec.2017.07.030. Epub 2017 Jul 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Reported compliance (questionnaire)	Assess changes of reported compliance throught HIV antiretroviral treatments (questionnaire)	Measured at the randomization and then immediately after the intervention
Secondary	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)
Secondary	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)
Secondary	Satisfaction of the intervention: questionnaire	Assess the satisfaction of the intervention using questionnaire	Measured immediately after the intervention

External Links

•   Gundo So program and adaptation