Clinical trial NCT03795415: ANRS12373 GUNDO SO - Evaluation of an Empowerment Program for WLHIV in Mali
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Seropositivity
Disclosure
Empowerment
HIV/AIDS
Keywords: WLHIV
empowerment
disclosure
Mali
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Fondation de France
name: Aix Marseille Université
name: Université du Québec a Montréal
name: Centre Population et Développement (CEPED), Paris, France
name: ARCAD-SIDA MALI
name: Groupe de Recherche en Psychologie Sociale (GRePS), Bron, France
name: Coalition Plus, France
First posted: 2019-01-07
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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?

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).

Eligibility criteria: 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

Primary outcomes:
measure: Short term evaluation of the burden associated with the disclosure issue using questionnaires
timeFrame: 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
measure: Short term evaluation of the burden associated with the secrecy issue using questionnaires
timeFrame: 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
measure: Mid term evaluation of the burden associated with the disclosure issue using questionnaires
timeFrame: The mid term effect will be measured 9 months after the intervention : up to 9 months after the intervention
measure: Mid term evaluation of the burden associated with the secrecy issue using questionnaires
timeFrame: The mid term effect will be measured 9 months after the intervention : up to 9 months after the intervention
Secondary outcomes:
measure: Changes in quality of life of WLHIV: questionnaire
timeFrame: Measured at the randomization and then immediately after the intervention
measure: Evolution of sexual practices and use of risk reduction strategies
timeFrame: Measured at the randomization and then immediately after the intervention
measure: Reported compliance (questionnaire)
timeFrame: Measured at the randomization and then immediately after the intervention
measure: Biological data : HIV viral load
timeFrame: From 6 months before the intervention until the last follow up (total 2 years)
measure: Biological data : cluster of differentiation 4 levels
timeFrame: From 6 months before the intervention until the last follow up (total 2 years)
measure: Satisfaction of the intervention: questionnaire
timeFrame: Measured immediately after the intervention
Other outcomes:
Locations:
city: Bamako
country: Mali
facility: CESAC de BAMAKO
city: Bamako
country: Mali
facility: Usac Cnam
city: Bamako
country: Mali
facility: USAC commune IV
city: Bamako
country: Mali
facility: USAC commune I
city: Bamako
country: Mali
facility: USAC commune VI
city: Bamako
country: Mali
facility: USAC commune V
Study officials:
affiliation: GRePS
name: Marie Préau, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.