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

ANRS, Emerging Infectious Diseases

Status: Completed

Conditions: HIV Infection

Treatments: Other: HIV quarterly global care

Study type: Interventional

Funder types: Other

Identifiers

NCT02626286

ANRS 12324 CohMSM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 885 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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885 participants in 1 patient group

HIV quarterly global care

Other group

Description:

HIV quarterly 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) prevention counselling adapted for MSM, v) the provision of condoms and lubricants, and vi) HIV screening test at each quarterly visit for HIV-negative MSM or immediate support of HIV infection including antiretroviral therapy for HIV-positive MSM.

Treatment:

Other: HIV quarterly global care