Feasibility and Interest of a HIV Quarterly Preventive Global Care in Men Who Have Sex With Men in Sub-Saharan Africa

HIV Infection Clinical Trial

— CohMSM  

Official title:

Prevention of HIV Infection in Men Who Have Sex With Men in Sub-Saharan Africa: Feasibility and Interest of a Quarterly Preventive Global Care (CohMSM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02626286
• Other study ID #: ANRS 12324 CohMSM
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: January 5, 2021

Study information

• Verified date: April 2021
• Source: ANRS, Emerging Infectious Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to evaluate the feasibility and interest of a HIV quarterly preventive global care for men who have sex with men (MSM) in sub-Saharan Africa to help reducing HIV incidence in this key population, their female partners, and the general population. This interventional, open label, multicenter, multidisciplinary cohort study will be conducted in Burkina Faso, Ivory Coast, Mali and Togo. All participants will receive a HIV quarterly preventive global care including: i) data collection on health status, symptoms of sexually transmitted infections (STI) and sexual behavior, ii) a clinical examination, iii) STI diagnosis and treatment, iv) counselling adapted for MSM, and v) the provision of condoms and lubricants.

Description:

The objective of the study is to evaluate the feasibility and interest of a HIV quarterly preventive global care for men who have sex with men (MSM) in sub-Saharan Africa to help reducing HIV incidence in this key population, their female partners, and the general population. Regarding HIV-negative MSM, the specific objectives are to assess: 1. the acceptability of the preventive global care including quarterly monitoring and HIV screening as well as the associated medical, behavioral and social factors, and 2. changes in sexual behavior among MSM during the project as well as the associated medical, behavioral and social factors. Regarding HIV-positive MSM, the specific objectives are to assess: 1. the acceptability of the preventive global care including antiretroviral therapy initiation whatever the CD4 T cell count and the clinical stage, as well as the associated medical, behavioral and social factors, 2. adherence and response to antiretroviral therapy as well as the associated medical, behavioral and social factors, 3. changes in sexual behavior among MSM during the project as well as the associated medical, behavioral and social factors, 4. risk of HIV transmission as well as the associated medical, behavioral and social factors, and 5. describe the virologic characteristics (subtypes / circulating recombinant forms, co-infection with multiple variants and transmitted and acquired resistance profiles). Regarding healthcare professionals, the specific objective is to evaluate the perception of the preventive global care. This interventional, open label, multicenter, multidisciplinary cohort study will be conducted in Burkina Faso, Ivory Coast, Mali and Togo. All participants will receive a HIV quarterly preventive global care including: i) data collection on health status, symptoms of sexually transmitted infections (STI) and sexual behavior, ii) a clinical examination, iii) STI diagnosis and treatment, iv) counselling adapted for MSM, and v) the provision of condoms and lubricants. In addition, vaccination against hepatitis B virus and annual tests for syphilis will be offered. HIV-negative MSM will also be offered an HIV screening test at each quarterly visit. HIV-positive MSM will be offered immediate support of HIV infection including antiretroviral therapy. A total of 700 MSM over 18 years (500 HIV-negative and 200 HIV-positive) reporting at least one anal sex (passive or active) with another man within the last three months will be recruited and followed for 24 to 36 months. MSM lost to follow-up, transferred, died or having seroconverted for HIV during follow-up will be replaced in their respective group (seronegative or seropositive) by other MSM. The study will last 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 885
• Est. completion date: January 5, 2021
• Est. primary completion date: January 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Man over 18 years
• Reporting at least one anal sex (passive or active) with another man within the last three months
• Able to reach the local site of the study
• Agreeing to participate in the study and signing the informed consent form

Exclusion Criteria:

• History of antiretroviral therapy (except for pre- or post-exposure prophylaxis)
• Participation in another biomedical or behavioral research on HIV or sexually transmitted infections
• Impairment of the person making his participation in the study, or information understanding, difficult or impossible
• Predictable protocol violation (geographical distance or other reasons)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infection
• HIV Infections
• Infection

Intervention

Other:
• HIV quarterly global care

Locations

Country	Name	City	State
Burkina Faso	Centre Oasis, Association African Solidarité (AAS)	Ouagadougou
Côte D'Ivoire	Clinique de Confiance, Espace Confiance	Abidjan
Mali	Clinique des Halles, ARCAD-SIDA	Bamako
Togo	Espoir vie Togo	Lome

Sponsors (11)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases	ARCAD-SIDA MALI, Association African Solidarité, Centre de Recherche Internationale pour la Santé, Ouagadougou, Burkina Faso, Coalition Internationale Sida, Espace Confiance, Côte d'Ivoire, Espoir Vie-Togo - ONG, Expertise France, IRD Unité SESSTIM (IRD, Inserm, Université Aix-Marseille), Programme PAC-CI, Abidjan, Côte d'Ivoire, Université Montpellier

Countries where clinical trial is conducted

Burkina Faso,  Côte D'Ivoire,  Mali,  Togo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of people followed after 3 years compared to the number of persons included (retention in the program)		3 years
Primary	Percentage of performed visits/scheduled visits		3 years
Primary	Percentage of performed tests/scheduled tests		3 years
Primary	Incidence of sexually transmitted infections		3 years
Primary	Number of unprotected anal sex		3 years
Primary	Antiretroviral therapy initiation probability in HIV-positive MSM		3 years
Primary	Antiretroviral therapy maintenance probability in HIV-positive MSM		3 years
Primary	Percentage of antiretroviral therapy observance in HIV-positive MSM		3 years
Primary	Percentage of HIV-positive MSM with viral load>1000 copies/mL		3 years
Primary	Percentage of HIV-positive MSM with CD4=reference (or CD4<100/mm3)		3 years
Primary	Percentage of HIV-positive MSM with new or recurrent AIDS-defining events (clinical stage 4)		3 years
Primary	Percentage of HIV-positive MSM died under antiretroviral therapy		3 years
Primary	Percentage of HIV-positive MSM with detectable viral load and inconsistent condom use with a partner seronegative or with unknown HIV status		3 years
Primary	Number of HIV subtypes / circulating recombinant forms		3 years
Primary	Number of co-infections with several viral variants		3 years
Primary	Number of transmitted and acquired resistance mutations		3 years
Primary	Number of male sex partners		3 years