Infection, Human Immunodeficiency VirusNCT03310515
Incidence of Human Immunodeficiency Virus-1 (HIV-1) Infection in HIV-1 Uninfected High Risk Men Who Have Sex With Men
An observational study of Infection, Human Immunodeficiency Virus and HIV Infections, run by ViiV Healthcare at 9 sites in China.
Trial summary
Studies to assess the effectiveness of interventions to prevent HIV infection depend upon robust estimates of Baseline HIV incidence rates. The changing landscape of high-risk populations, as well as the evolution of biomedical pre-exposure prophylaxis (PrEP) interventions, requires a contemporary evaluation of HIV… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection, Human Immunodeficiency Virus, HIV Infections
- What is being tested?
- Risk reduction counseling, Social harm interview and Computer-Assisted Self Interviewing technique
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 578 participants
- Where
- 9 sitesChina
- Study dates
- 31 Aug 2017to 31 Dec 2018
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This prospective cohort study will involve population of HIV-1 uninfected Chinese MSM and TGW who are at high-risk of HIV infection.
Who may be able to join
- Subjects are Chinese MSM and/or TGW and must be 18 years or older at the time of screening.
- Subjects of male sex at birth and who have sex with men, who in the 6 months prior to screening report one or more of the following risk criteria:
- Unprotected (condomless) receptive anal intercourse with one or more partners.
- More than five partners in the 6 months prior to enrolment (regardless of condom use and HIV serostatus, as reported by the enrolee).
- Reported STI with syphilis, gonorrhea, chlamydia, chancroid, or lymphogranuloma venereum.
- Subjects in a monogamous relationship with an HIV-1 seronegative partner or a virologically-suppressed HIV-1 + partner for >1 year are not eligible for participation.
Show all 9Show fewer
- Males, agree to appropriate use of contraceptive measures during heterosexual intercourse.
- Subjects who have non reactive fourth generation HIV test and undetectable HIV-1 RNA at screening.
- Capable of giving signed informed consent.
Who cannot join
- Subjects with known moderate to severe hepatic impairment as per liver function test criteria outlined below.
- Subject who, in the investigator's judgment, poses a significant suicide risk.
- The Subject has a tattoo or other dermatological condition overlying the gluteus region.
- Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease.
- Use of PrEP or post exposure prophylaxis (PEP) within the last 30 days prior to screening.
- Current use or anticipated need for use high dose aspirin or other anticoagulants including antiplatelet medications that would interfere with the ability to receive intramuscular (IM) injections.
Show all 23Show fewer
- Exposure to an experimental drug and/or experimental vaccine within 28 days or 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the screening.
- Anti-tuberculosis therapy.
- Alcohol use that in the judgment of the investigator would interfere with the subject's ability to complete study procedures.
- Active injection drug use that in the judgment of the investigator would interfere with the subject's ability to complete study procedures.
- Any medical condition, including psychiatric conditions, that in the judgment of the investigator would interfere with the subject's ability to complete study procedures.
- A reactive HIV test at screening.
- A positive Hepatitis B surface antigen.
- A positive Hepatitis C antibody with an HCV viral ribose nucleic acid (RNA) above the lower limit of detection.
- Any of the following laboratory values at screening:
- Hemoglobin (Hgb) <11 gram per deciliter (g/dL).
- Absolute neutrophil count <750 cells per cubic millimeter (cells/mm^3).
- Platelet count <100,000 cells/mm^3.
- Presence of a coagulopathy defined by an international normalized ratio (INR)>1.5 or a partial thromboplastin time (PTT)>45 seconds.
- Creatinine clearance <60 milliliter per minute (mL/min) using the Cockroft-Gault equation.
- Aspartate aminotransferase (AST) >1.5 times upper limit of normal (ULN).
- Direct Bilirubin >2.0 milligram per deciliter (mg/dL).
- Co-enrolment in any other HIV interventional studies.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
GSK Investigational Site
Beijing, 100015
GSK Investigational Site
Beijing, 100069
GSK Investigational Site
Changsha, 410005
GSK Investigational Site
Chengdu, Sichuan, 610066
GSK Investigational Site
Guangzhou, Guangdong, 510060
GSK Investigational Site
Hangzhou, Zhejiang, 310000
GSK Investigational Site
Shanghai, 201508
GSK Investigational Site
Shenyang, Liaoning, 110001
GSK Investigational Site
Shenzhen, 518020
About this study
Official title: A Cohort Study to Determine the Incidence of HIV-1 Infection in HIV-1 Uninfected High Risk Participants Who Are Male Sex at Birth and Have Sex With Men
Studies to assess the effectiveness of interventions to prevent HIV infection depend upon robust estimates of Baseline HIV incidence rates. The changing landscape of high-risk populations, as well as the evolution of biomedical pre-exposure prophylaxis (PrEP) interventions, requires a contemporary evaluation of HIV incidence as well as demographic, behavioral and other subject factors which may impact HIV incidence. This is a prospective cohort study to measure HIV-1 seroincidence in a study population of HIV-1 uninfected Chinese men who have sex with men (MSM) and transgender women (TGW) who are at high-risk of HIV infection. Approximately 550 subjects who are male sex at birth and have sex with men shall enter the study, which will allow for a 10% drop out rate to maintain 500 subjects at the conclusion of the cohort. This is a single arm cohort study to determine HIV-1 seroincidence rates in high risk MSM and TGW when combined with a comprehensive prevention package including HIV and safe sex counseling, provision of condoms and water-based lubricant, and sexually transmitted infection (STI) screening and referral for treatment. It will be determined what proportion of high-risk MSM and TGW who are given a comprehensive HIV-1 prevention package will acquire HIV-1 infection.
- Being tested
- Risk reduction counseling, Social harm interview, Computer-Assisted Self Interviewing technique
- Keywords
- PrEP, MSM, seroincidence, HIV-1, TGW, STIs
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome, HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk reduction counselingBehavioural
Subjects will receive comprehensive prevention package including HIV and safe sex counseling, provision of condoms and water-based lubricant, and STI screening and referral for treatment.
Social harm interviewOther
Information regarding social harms (loss of privacy, stigmatization, interference with gainful employment, and coercion) will be solicited during bi-monthly study visits after enrollment in the study and will be recorded. Subjects who report social harms will be referred to speak with a social worker and/or a study counselor.
Computer-Assisted Self Interviewing techniqueOther
Demographic, behavioral, and psychosocial factors associated with HIV acquisition will be assessed by CASI.
| Study group | Role | What they receive |
|---|---|---|
| HIV-1 uninfected high risk subjects | The study will involve HIV-1 uninfected high risk MSM and TGW subjects. They will receive comprehensive prevention package including HIV and safe sex counseling, provision of condoms and water-based lubricant, and STI screening and referral for treatment. Visits will include Baseline screening for HIV followed by screenings at Day 1, Weeks 5, 9, and 8 week intervals thereafter until study conclusion. Screening for other STIs will occur at Baseline, Week 9, and every 16 weeks thereafter. Receives: Behavioral: Risk reduction counseling; Other: Social harm interview; Other: Computer-Assisted Self Interviewing technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV-1 seroincidence rate in a cohort of high-risk MSM and TGW
Incidence of HIV-1 infection in subject's post-study entry will be assessed by determining number of subjects who become infected with HIV-1 post-screening and after study entry including Day 1 and subsequent observation visits. Confirmatory HIV serology test will be performed at seroconversion visit.
Measured: Baseline, Day 1, Weeks 5, 9, and every 8 week intervals thereafter until study completion, an average of 12 months
HIV-1 seroincidence rate in a cohort of high-risk TGW
Incidence of HIV-1 infection in subject's post-study entry will be assessed by determining number of subjects who become infected with HIV-1 post-screening and after study entry including Day 1 and subsequent observation visits. Confirmatory HIV serology test will be performed at seroconversion visit.
Measured: Baseline, Day 1, Weeks 5, 9, and every 8 week intervals thereafter until study completion, an average of 12 months
Secondary outcomes (3)
Number of subjects diagnosed with gonorrhea, chlamydia, and syphilis post screening
Infections like gonorrhea, chlamydia, and syphilis will be assessed by toluidine red unheated serum test (TRUST) for syphilis and STI testing.
Measured: Day 1, Week 9, and every 16 weeks interval thereafter until study completion, an average of 12 months
Number of subjects with demographic factors
Demographic factors associated with HIV seroconversion and STI acquisition will be assessed by computer-assisted self-interview (CASI).
Measured: Day 1, Week 9, and every 8 weeks interval thereafter until study completion, an average of 12 months
Number of subjects enrolled and retained in to the study
Measures will be utilized to effectively engage and retain the subjects in the study. Retention strategies to be studied may include community engagement, interpersonal relationship building and reduction of external barriers.
Measured: Day 1, Weeks 5, 9, and every 8 or 16 weeks interval thereafter until study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start31 Aug 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 578 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310515
- Sponsor's protocol ID
- 206897
- Status last verified
- Mar 2020
- First submitted
- 21 Sep 2017
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study to Determine the Incidence of HIV-1 Infection in HIV-1 Uninfected High Risk Participants Who Are Male Sex at Birth and Have Sex With Men
- ClinicalTrials.gov ID
- NCT03310515
- Acronym / sponsor ID
- 206897
- Keywords
- PrEP, MSM, seroincidence, HIV-1, TGW, STIs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 578 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 16 Oct 2017 (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.
Studies to assess the effectiveness of interventions to prevent HIV infection depend upon robust estimates of Baseline HIV incidence rates. The changing landscape of high-risk populations, as well as the evolution of biomedical pre-exposure prophylaxis (PrEP) interventions, requires a contemporary evaluation of HIV incidence as well as demographic, behavioral and other subject factors which may impact HIV incidence. This is a prospective cohort study to measure HIV-1 seroincidence in a study population of HIV-1 uninfected Chinese men who have sex with men (MSM) and transgender women (TGW) who are at high-risk of HIV infection. Approximately 550 subjects who are male sex at birth and have sex with men shall enter the study, which will allow for a 10% drop out rate to maintain 500 subjects at the conclusion of the cohort. This is a single arm cohort study to determine HIV-1 seroincidence rates in high risk MSM and TGW when combined with a comprehensive prevention package including HIV and safe sex counseling, provision of condoms and water-based lubricant, and sexually transmitted infection (STI) screening and referral for treatment. It will be determined what proportion of high-risk MSM and TGW who are given a comprehensive HIV-1 prevention package will acquire HIV-1 infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-1 uninfected high risk subjects | – | Behavioral: Risk reduction counseling, Other: Social harm interview, Other: Computer-Assisted Self Interviewing techniqueThe study will involve HIV-1 uninfected high risk MSM and TGW subjects. They will receive comprehensive prevention package including HIV and safe sex counseling, provision of condoms and water-based lubricant, and STI screening and referral for treatment. Visits will include Baseline screening for HIV followed by screenings at Day 1, Weeks 5, 9, and 8 week intervals thereafter until study conclusion. Screening for other STIs will occur at Baseline, Week 9, and every 16 weeks thereafter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective cohort study will involve population of HIV-1 uninfected Chinese MSM and TGW who are at high-risk of HIV infection.
Key inclusion criteria (9 listed)
- Subjects are Chinese MSM and/or TGW and must be 18 years or older at the time of screening.
- Subjects of male sex at birth and who have sex with men, who in the 6 months prior to screening report one or more of the following risk criteria:
- Subjects in a monogamous relationship with an HIV-1 seronegative partner or a virologically-suppressed HIV-1 + partner for >1 year are not eligible for participation.
- Males, agree to appropriate use of contraceptive measures during heterosexual intercourse.
- Subjects who have non reactive fourth generation HIV test and undetectable HIV-1 RNA at screening.
Key exclusion criteria (23 listed)
- Subjects with known moderate to severe hepatic impairment as per liver function test criteria outlined below.
- Subject who, in the investigator's judgment, poses a significant suicide risk.
- The Subject has a tattoo or other dermatological condition overlying the gluteus region.
- Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease.
- Use of PrEP or post exposure prophylaxis (PEP) within the last 30 days prior to screening.
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 |
|---|---|---|
| Risk reduction counselingSubjects will receive comprehensive prevention package including HIV and safe sex counseling, provision of condoms and water-based lubricant, and STI screening and referral for treatment. | Behavioural | HIV-1 uninfected high risk subjects |
| Social harm interviewInformation regarding social harms (loss of privacy, stigmatization, interference with gainful employment, and coercion) will be solicited during bi-monthly study visits after enrollment in the study and will be recorded. Subjects who report social harms will be referred to speak with a social worker and/or a study counselor. | Other | HIV-1 uninfected high risk subjects |
| Computer-Assisted Self Interviewing techniqueDemographic, behavioral, and psychosocial factors associated with HIV acquisition will be assessed by CASI. | Other | HIV-1 uninfected high risk subjects |
Primary outcome
HIV-1 seroincidence rate in a cohort of high-risk MSM and TGW
Time frame: Baseline, Day 1, Weeks 5, 9, and every 8 week intervals thereafter until study completion, an average of 12 months
Incidence of HIV-1 infection in subject's post-study entry will be assessed by determining number of subjects who become infected with HIV-1 post-screening and after study entry including Day 1 and subsequent observation visits. Confirmatory HIV serology test will be performed at seroconversion visit.
HIV-1 seroincidence rate in a cohort of high-risk TGW
Time frame: Baseline, Day 1, Weeks 5, 9, and every 8 week intervals thereafter until study completion, an average of 12 months
Incidence of HIV-1 infection in subject's post-study entry will be assessed by determining number of subjects who become infected with HIV-1 post-screening and after study entry including Day 1 and subsequent observation visits. Confirmatory HIV serology test will be performed at seroconversion visit.
3 secondary outcomes
Number of subjects diagnosed with gonorrhea, chlamydia, and syphilis post screening
Time frame: Day 1, Week 9, and every 16 weeks interval thereafter until study completion, an average of 12 months
Number of subjects with demographic factors
Time frame: Day 1, Week 9, and every 8 weeks interval thereafter until study completion, an average of 12 months
Number of subjects enrolled and retained in to the study
Time frame: Day 1, Weeks 5, 9, and every 8 or 16 weeks interval thereafter until study completion, an average of 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
Related trials for Infection, Human Immunodeficiency Virus
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
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.
GSK Clinical Trials study director
ViiV Healthcare
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, Human Immunodeficiency Virus and HIV Infections, run by ViiV Healthcare at 9 sites in China.
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 9 inclusion and 23 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: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV-1 seroincidence rate in a cohort of high-risk MSM and TGW (time frame: Baseline, Day 1, Weeks 5, 9, and every 8 week intervals thereafter until study completion, an average of 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2020.