HIV SeropositivityNCT03795415
ANRS12373 GUNDO SO - Evaluation of an Empowerment Program for WLHIV in Mali
An observational study of HIV Seropositivity and Disclosure, run by ANRS, Emerging Infectious Diseases at 6 sites in Mali.
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". Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Seropositivity, Disclosure, Empowerment
- What is being tested?
- Gundo So
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 224 participants
- Where
- 6 sitesMali
- Study dates
- 27 May 2019to May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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?
Who may be able to join
- 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.
Who cannot join
- having already participated in Gundo-So
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Mali6 sites, 6 recruiting
- Recruiting
CESAC de BAMAKO
Bamako
Djénébou Traoré, Dr
- Recruiting
Usac Cnam
Bamako
Djénébou Traore, Dr
- Recruiting
USAC commune IV
Bamako
Djénébou Traoré, Dr
- Recruiting
USAC commune I
Bamako
Djénébou Traore, Dr
- Recruiting
USAC commune VI
Bamako
Djénébou Traore, Dr
- Recruiting
USAC commune V
Bamako
Djénébou Traore, Dr
About this study
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
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".
Read the 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).
- Conditions
- HIV Seropositivity, Disclosure, Empowerment, HIV/AIDS
- Being tested
- Gundo So
- Keywords
- WLHIV, empowerment, disclosure, Mali
- Medical subject headings
- HIV Seropositivity, Empowerment, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gundo SoBehavioural
Also called Gundo So - The room of confidences
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Gundo So | |
| 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. Receives: Behavioral: Gundo So |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: The mid term effect will be measured 9 months after the intervention : up to 9 months after the intervention
Secondary outcomes (6)
Changes in quality of life of WLHIV: questionnaire
Assess the changes in quality of life (questionnaire)
Measured: 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: Measured at the randomization and then immediately after the intervention
Reported compliance (questionnaire)
Assess changes of reported compliance throught HIV antiretroviral treatments (questionnaire)
Measured: 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)
Measured: 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)
Measured: 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: Measured immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start27 May 2019
- Primary completionFeb 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Fondation de France, Aix Marseille Université, 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
- Responsible party
- Sponsor
- Investigators
- Marie Préau, Pr, Principal investigator, GRePS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795415
- Sponsor's protocol ID
- ANRS12373
- Status last verified
- Jul 2019
- First submitted
- 15 Jun 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 28789863
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03795415
- Acronym / sponsor ID
- ANRS12373
- Conditions
- HIV Seropositivity, Disclosure, Empowerment, HIV/AIDS
- Keywords
- WLHIV, empowerment, disclosure, Mali
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Fondation de France, Aix Marseille Université, 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
- Study start
- 27 May 2019 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 7 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Arm (G1) | – | Behavioral: 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) | – | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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?
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- having already participated in Gundo-So
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gundo SoAlso: Gundo So - The room of confidencesGundo-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. | Behavioural | Delayed Arm (G2), Immediate Arm (G1) |
Primary outcome
Short term evaluation of the burden associated with the disclosure issue using questionnaires
Time frame: 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
Improvement 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 questionnaires
Time frame: 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
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 questionnaires
Time frame: The 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 questionnaires
Time frame: The 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)
6 secondary outcomes
Changes in quality of life of WLHIV: questionnaire
Time frame: Measured at the randomization and then immediately after the intervention
Evolution of sexual practices and use of risk reduction strategies
Time frame: Measured at the randomization and then immediately after the intervention
Reported compliance (questionnaire)
Time frame: Measured at the randomization and then immediately after the intervention
Biological data : HIV viral load
Time frame: From 6 months before the intervention until the last follow up (total 2 years)
Biological data : cluster of differentiation 4 levels
Time frame: From 6 months before the intervention until the last follow up (total 2 years)
Satisfaction of the intervention: questionnaire
Time frame: Measured immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Background: PubMed 28789863Bernier 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Préau, Pr principal investigator
GRePS
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Seropositivity and Disclosure, run by ANRS, Emerging Infectious Diseases at 6 sites in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucas Riegel (+33 1 77 93 97 63, lriegel@coalitionplus.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term evaluation of the burden associated with the disclosure issue using questionnaires (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03795415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.