NCT03795415

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".

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

May 27, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

8 months

First QC Date

June 15, 2018

Last Update Submit

July 2, 2019

Conditions

HIV SeropositivityDisclosureEmpowermentHIV/AIDS

Keywords

WLHIVempowermentdisclosureMali

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • Changes in quality of life of WLHIV: questionnaire

    Measured at the randomization and then immediately after the intervention

  • Evolution of sexual practices and use of risk reduction strategies

    Measured at the randomization and then immediately after the intervention

  • Reported compliance (questionnaire)

    Measured at the randomization and then immediately after the intervention

  • Biological data : HIV viral load

    From 6 months before the intervention until the last follow up (total 2 years)

  • Biological data : cluster of differentiation 4 levels

    From 6 months before the intervention until the last follow up (total 2 years)

  • +1 more secondary outcomes

Study Arms (2)

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

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

Interventions

Gundo SoBEHAVIORAL

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.

Also known as: Gundo So - The room of confidences
Delayed Arm (G2)Immediate Arm (G1)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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?

You may qualify if:

  • 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.

You may not qualify if:

  • having already participated in Gundo-So

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CESAC de BAMAKO

Bamako, Mali

RECRUITING

Usac Cnam

Bamako, Mali

RECRUITING

USAC commune IV

Bamako, Mali

RECRUITING

USAC commune I

Bamako, Mali

RECRUITING

USAC commune VI

Bamako, Mali

RECRUITING

USAC commune V

Bamako, Mali

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28789863BACKGROUND

MeSH Terms

Conditions

HIV SeropositivityEmpowermentAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSocial BehaviorBehaviorSlow Virus Diseases

Study Officials

  • Marie Préau, Pr

    GRePS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucas Riegel

CONTACT

+33 1 77 93 97 63lriegel@coalitionplus.org

Marie Préau, Pr

CONTACT

+33 4 78 77 31 63marie.preau@univ-lyon2.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2018

First Posted

January 7, 2019

Study Start

May 27, 2019

Primary Completion

February 1, 2020

Study Completion

May 1, 2021

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations

MA(6)