An interventional study of HIV quarterly global care in HIV Infection, sponsored by ANRS, Emerging Infectious Diseases. Completed at 4 sites in 4 countries. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by ANRS, Emerging Infectious Diseases · Not applicable, Interventional, and Prevention
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.
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:
Regarding HIV-positive MSM, the specific objectives are to assess:
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 885 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →ANRS, Emerging Infectious Diseases is the lead sponsor of 215 studies on the registry; 38 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: HIV quarterly global care
Number of people followed after 3 years compared to the number of persons included (retention in the program)
Time frame: 3 years
Percentage of performed visits/scheduled visits
Time frame: 3 years
Percentage of performed tests/scheduled tests
Time frame: 3 years
Incidence of sexually transmitted infections
Time frame: 3 years
Number of unprotected anal sex
Time frame: 3 years
Antiretroviral therapy initiation probability in HIV-positive MSM
Time frame: 3 years
Antiretroviral therapy maintenance probability in HIV-positive MSM
Time frame: 3 years
Percentage of antiretroviral therapy observance in HIV-positive MSM
Time frame: 3 years
Percentage of HIV-positive MSM with viral load>1000 copies/mL
Time frame: 3 years
Percentage of HIV-positive MSM with CD4≤reference (or CD4<100/mm3)
Time frame: 3 years
Percentage of HIV-positive MSM with new or recurrent AIDS-defining events (clinical stage 4)
Time frame: 3 years
Percentage of HIV-positive MSM died under antiretroviral therapy
Time frame: 3 years
Percentage of HIV-positive MSM with detectable viral load and inconsistent condom use with a partner seronegative or with unknown HIV status
Time frame: 3 years
Number of HIV subtypes / circulating recombinant forms
Time frame: 3 years
Number of co-infections with several viral variants
Time frame: 3 years
Number of transmitted and acquired resistance mutations
Time frame: 3 years
Number of male sex partners
Time frame: 3 years
Ran from Jun 2015 to primary completion in Jan 2021, 67 months.
Of 393 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's 67 months is above that.
Counting every sponsor, half of 402 studies reached it within 28 months; a quarter within 16 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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ANRS, Emerging Infectious Diseases →