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

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".

Study Overview

• Status: Unknown
• Conditions: HIV/AIDS; HIV Seropositivity; Empowerment; Disclosure
• Intervention / Treatment: Behavioral: Gundo So

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).

• Study Type: Observational
• Enrollment (Anticipated): 224

Contacts and Locations

Study Locations

• Mali
  • Bamako, Mali
    • Recruiting
    • CESAC de BAMAKO
    • Contact: Djénébou Traore, Dr
  • Bamako, Mali
    • Recruiting
    • Usac Cnam
    • Contact: Djénébou Traore, Dr
  • Bamako, Mali
    • Recruiting
    • USAC commune IV
    • Contact: Djénébou Traore, Dr
  • Bamako, Mali
    • Recruiting
    • USAC commune I
    • Contact: Djénébou Traore, Dr
  • Bamako, Mali
    • Recruiting
    • USAC commune VI
    • Contact: Djénébou Traore, Dr
  • Bamako, Mali
    • Recruiting
    • USAC commune V
    • Contact: Djénébou Traore, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The programm Gundo So has been adapted for groups of malian women living with HIV (WLHIV). The study population is described with the inclusion criteria. Moreover, in order to participate at this research, women have to answer "Yes" at at least one of those 2 questions :

• (1) is it difficult for you to share your HIV serostatus ; and (1.1) is it inconvenient for you?
• (2) is it difficult for you to keep your HIV serostatus secret; and (2.1) is it inconvenient for you?

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Immediate Arm (G1); 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; 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.; Other Names: Gundo So - The room of confidences
Delayed Arm (G2); 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; 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.; Other Names: Gundo So - The room of confidences

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Collaborators: Aix Marseille Université; Fondation de France; Université du Québec a Montréal; Centre Population et Développement (CEPED), Paris, France; ARCAD-SIDA MALI; Groupe de Recherche en Psychologie Sociale (GRePS), Bron, France; Coalition Plus, France
• Investigators: Principal Investigator: Marie Préau, Pr, GRePS

Publications and helpful links

General Publications

• Bernier A, Yattassaye A, Beaulieu-Prevost D, Otis J, Henry E, Flores-Aranda J, Massie L, Preau 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2019
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: June 15, 2018
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 7, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: disclosure; empowerment; Mali; WLHIV
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; HIV Seropositivity
• Other Study ID Numbers: ANRS12373

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No