HIV SeropositivityNCT04044586
HIV and HCV Infections in 2 Communes From the Battambang Province, Cambodia: Prevalence Rates, Viral Strains, and Unsafe Injection Practices (12352 ANRS ROK INVEST)
An observational study of HIV Seropositivity and HCV Infection, run by ANRS, Emerging Infectious Diseases at 1 site in Cambodia.
Trial summary
This cross-sectional survey will be conducted prospectively in 2 communes in the Battambang Province, Roka and Prey Khpos commune. The principal objective of the study is to compare HIV and HCV prevalence rates in three groups of subjects as follows: Group 1: subjects living in Roka and Ambaeng Thngae villages where… Read more about this study
- Who is it for?
- Ages 18 months and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Seropositivity, HCV Infection
- How many people
- 1,098 participants
- Where
- 1 siteCambodia
- Study dates
- 1 Sep 2019to 1 Mar 2020
- 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 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Three groups of subject will be selected: Group 1: subjects living in Roka and Ambaeng Thngae villages where most of HIV and HCV cases were identified during the Roka outbreak; Group 2: subjects living in the other 4 villages of the Roka commune (Ta Haen I and II, Pou Batdambang, and Chhung Tradak) and Group 3: subjects living in villages from Prey Khpos commune belonging to the Battambang Province. The minimum sample size of 366 is required per group. Therefore, the total sample size for the 3 groups of subjects will be 1,098 individuals.
Who may be able to join
- Children aged from 18 months to 14 years old
- Adult aged ≥ 15 years old
- Informed consent from the participant/parents
- Resident from the selected villages
Who cannot join
- Children aged less than 18 months
Trial locations and contacts
1 site in 1 country.
About this study
This cross-sectional survey will be conducted prospectively in 2 communes in the Battambang Province, Roka and Prey Khpos commune. The principal objective of the study is to compare HIV and HCV prevalence rates in three groups of subjects as follows:
- Group 1: subjects living in Roka and Ambaeng Thngae villages where most of HIV and HCV cases were identified during the Roka outbreak in 2014-2015
- Group 2: subjects living in the other 4 villages of the Roka commune (Ta Haen I and II, Pou Batdambang, and Chhung Tradak)
- Group 3: subjects living in selected villages from Prey Khpos commune 1,098 eligible residents will be selected using three-stage cluster sampling method. A structure questionnaire will assess the medical injection practices through face-to-face interview. The study will be conducted into two steps. The first step will be a prevalence study to assess HIV and HCV prevalence rates in three groups of subject; Group 1: subjects living in Roka and Ambaeng Thngae villages where most of HIV and HCV cases were identified during the Roka outbreak; Group 2: subjects living in the other 4 villages of the Roka commune (Ta Haen I and II, Pou Batdambang, and Chhung Tradak) and Group 3: subjects living in villages from Prey Khpos commune).The second step will be the phylogenetic study of HIV. The phylogenetic study of HIV will be performed ONLY if HIV prevalence rates among group 2 and/or group 3 is higher or equal to 0.7% (upper limit of confidence interval of HIV prevalence estimated in Cambodia)
Read the detailed description
Objectives
- General objective The principal objective of the study is to compare HIV and HCV prevalence rates in three groups of subjects as follows:
- Group 1: subjects living in Roka and Ambaeng Thngae villages where most of HIV and HCV cases were identified during the Roka outbreak in 2014-2015
- Group 2: subjects living in the other 4 villages of the Roka commune (Ta Haen I and II, Pou Batdambang, and Chhung Tradak)
- Group 3: subjects living in selected villages from Prey Khpos commune belonging to the Battambang Province.
- Specific objectives
Given the results we obtained during the investigation of the Roka nosocomial outbreak (2014-15), specific objectives are defined as follows:
- Risk of geographical spread of clustered HCV strains from Roka or Ambaeng Thngae villages to other villages of the Roka commune
- Risk of geographical spread of clustered HIV strains from Roka or Ambaeng Thngae villages to other villages of the Roka commune if the HIV prevalence of Group 2 and/or Group 3 is higher or equal to 0.7% (upper limit of confidence interval of HIV prevalence estimated in Cambodia).
- Comparison of unsafe injection and/or medical practices between the three groups
Methodology This cross-sectional survey will be conducted prospectively in 2 communes in the Battambang Province, i.e. the Roka commune and Prey Khpos commune of the Battambang province. A total of 1,098 eligible residents will be selected according to a three-stage cluster sampling method conducted in the selected sites. A structure questionnaire will assess the medical injection practices through a face-to-face interview. The study will be conducted into two steps. The first step will be a prevalence study to assess HIV and HCV prevalence rates in three groups of subject; Group 1: subjects living in Roka and Ambaeng Thngae villages where most of HIV and HCV cases were identified during the Roka outbreak; Group 2: subjects living in the other 4 villages of the Roka commune (Ta Haen I and II, Pou Batdambang, and Chhung Tradak) and Group 3: subjects living in villages from Prey Khpos commune belonging to the Battambang Province.
The second step will be the phylogenetic study of HIV. The phylogenetic study of HIV will be performed ONLY if HIV prevalence rates among group 2 and/or group 3 is higher or equal to 0.7% (upper limit of confidence interval of HIV prevalence estimated in Cambodia). If the result of HIV prevalence rates among group 2 and group 3 is lower or equal to 0.6% (HIV prevalence estimated in Cambodia), the phylogenetic study of HIV will NOT be performed.
A blood test will be done for HIV and HCV serological antibody screening. For the participants known as HIV positive and/or under ART treatment with NCHADS or as HCV positive, HCV and/or HIV antibody test will not be repeated for these participants and they will be considered as HCV and/or HIV positive. All individuals who will test positive for HCV will be further assessed for viral load measurements. In case of detectable VL results in plasma HCV strains will be amplified, sequenced, and characterized.
In the second step, all individuals who will test positive for HIV will be further assessed for viral load measurements. In case of detectable VL results in plasma or by using whole blood and/or peripheral blood mononuclear cells (PBMCs) in case of undetectable plasma HIV-1 RNA VL results, viral HIV strains will be amplified, sequenced, and characterized.
All tested participants will get a referral slip to retrieve their results (or those from their child) at health care center in the coverage area. Result disclosure will be provided by the doctor (or midwife or nurse) in each center. In case of positive result for at least one virus, we'll advice for the spouse to be tested as well. The same will be suggested for mothers and/or fathers whose child will be identified as infected. The transportation fee for this referral will be offered by the survey.
The total duration of this survey is expected to be 12 months.
Estimated enrollment 1,098 participants
Statistical methods
- Sample size The formula for two-group comparison was used to calculate the sample size, taking into account the design effect and refusal rate. The minimum sample size of 366 is required per group. Therefore, the total sample size for the 3 groups of subjects in the 2 communes in Battambang will be 1,098 individuals.
- Sampling strategies A three-stage cluster sampling method will be used to select the eligible participants among residents in the 2 communes in Battambang. This sampling method will be done according to three steps. First, we will select Roka and Prey Khpos Khpos commune in the Battambang province (a commune that looks alike Roka in terms of number of inhabitants is selected). Second, the Simple Random sampling will be used to select 1414 clusters (which are groups) for each group of study population. Third, simple random sampling strategy will be used to select 26 households from each cluster (group) and only one person will be selected per household. The next adjacent household will be used if the person is not present after 3 visits in the first visited household. If more than one person occupies the visited household, one participant will be randomly selected for blood test and face-to-face interview with the research team. If the selected participant is a child, the face-to-face interviews will be done with parent/legal guardian.
- Data analysis plan
Data analyses will include:
- Description of the participants' demographic characteristics,
- Comparison of HIV and HCV prevalence rates in 3 different groups (subjects living in Roka and Ambaeng Thngae villages of Roka commune, individuals living in the other 4 villages of the Roka commune, and people living in other villages of Prey Khpos commune in the Battambang) using Chi-squared test,
- Comparison of injection history in subjects living in Roka and Ambaeng Thngae villages of Roka versus residents from other villages using Chi-squared test,
- Comparison of viral strains circulating in Roka and Ambaeng Thngae villages of Roka commune versus those present in other villages.
Finally, multiple logistic regression models will be used to assess the independence of variables. All statistical analysis will be performed using STATA version 13.1 software (StataCorp LP, College Station, USA).
Survey timetable Survey start date: Second semester of 2019 Enrolment period: 2 months Subject participation duration: Cross-sectional study Total survey duration: 12 months Estimated survey/trial completion date: Second semester of 2020
- Conditions
- HIV Seropositivity, HCV Infection
- Keywords
- HIV, HCV, outbreak, prevalence
- Medical subject headings
- HIV Seropositivity, Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of HIV and HCV prevalence rates in 2 communes in Battambang province, as well as basic epidemiological risk factors associated with HIV and HCV infections.
For the initial screening, ELISA techniques (Murex) will be used for HIV and HCV antibody (Ab) testing. In case of Ab positivity (for HIV and HCV), VL testing will be performed using the Biocentric HIV RNA assay, and the Omunis HCV RNA Viral Load technique.
In case of detectable (>1,000 copies/ml) HIV and/or HCV VL results or using peripheral blood mononuclear cells (PBMCs) and/or DBS in case of undetectable plasma HIV-1 RNA VL results, viral strains will be amplified and sequenced by Macrogen as follows: C2V3 env region for HIV, and NS5B gene for HCV.
The phylogenetic analyses will be done for HCV and for HIV using maximum likelihood tree inference and Bayesian evolutionary analyses to obtain temporal information about the date of origin and age of strains (according to 'molecular clock' approaches). Phylogenetic analysis will be performed with the MEGA6 and BEAST softwares.
Measured: July 2019-December 2020
Secondary outcomes (1)
2/ Phylogenetic characterization of HCV strains circulating in these areas. 3/ Assessment of injection practices among tested subjects enrolled from the 2 studied communes.
The survey will assess the knowledge about medical injections practices and beliefs about efficacy of injections among participants using a questionnaire advocated by the WHO and based on previous results described in literature related to injection practices, consists of structured close-ended questions and will include basic demographic, history of medical injections or IV infusions, history of other medical practices as surgery, endoscopy, dental care, assessment of sexual risk behaviors, beliefs about the efficacy of injections and beliefs about the efficacy of parenteral injections. Other exposure factors will be also included in the questionnaire, such as blood transfusion, haemodialysis, tattooing, etc.
Measured: July 2019-December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start1 Sep 2019
- Primary completion30 Sep 2019
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,098 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- University of Health Sciences, Cambodia, Hopital Paul Brousse
- Responsible party
- Sponsor
- Investigators
- Vonthanak SAPHONN, Principal investigator, University of Health Sciences, Cambodia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044586
- Sponsor's protocol ID
- ANRS 12352 ROK INVEST
- Status last verified
- Oct 2019
- First submitted
- 1 Aug 2019
- Last updated
- 22 Oct 2019
- 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 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV and HCV Infections in 2 Communes From the Battambang Province, Cambodia: Prevalence Rates, Viral Strains, and Unsafe Injection Practices (12352 ANRS ROK INVEST)
- ClinicalTrials.gov ID
- NCT04044586
- Acronym / sponsor ID
- ANRS 12352 ROK INVEST
- Conditions
- HIV Seropositivity, HCV Infection
- Keywords
- HIV, HCV, outbreak, prevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,098 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- University of Health Sciences, Cambodia, Hopital Paul Brousse
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 5 Aug 2019 (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.
This cross-sectional survey will be conducted prospectively in 2 communes in the Battambang Province, Roka and Prey Khpos commune. The principal objective of the study is to compare HIV and HCV prevalence rates in three groups of subjects as follows:
- Group 1: subjects living in Roka and Ambaeng Thngae villages where most of HIV and HCV cases were identified during the Roka outbreak in 2014-2015
- Group 2: subjects living in the other 4 villages of the Roka commune (Ta Haen I and II, Pou Batdambang, and Chhung Tradak)
- Group 3: subjects living in selected villages from Prey Khpos commune 1,098 eligible residents will be selected using three-stage cluster sampling method. A structure questionnaire will assess the medical injection practices through face-to-face interview. The study will be conducted into two steps. The first step will be a prevalence study to assess HIV and HCV prevalence rates in three groups of subject; Group 1: subjects living in Roka and Ambaeng Thngae villages where most of HIV and HCV cases were identified during the Roka outbreak; Group 2: subjects living in the other 4 villages of the Roka commune (Ta Haen I and II, Pou Batdambang, and Chhung Tradak) and Group 3: subjects living in villages from Prey Khpos commune).The second step will be the phylogenetic study of HIV. The phylogenetic study of HIV will be performed ONLY if HIV prevalence rates among group 2 and/or group 3 is higher or equal to 0.7% (upper limit of confidence interval of HIV prevalence estimated in Cambodia)
Detailed description
Objectives
- General objective The principal objective of the study is to compare HIV and HCV prevalence rates in three groups of subjects as follows:
- Group 1: subjects living in Roka and Ambaeng Thngae villages where most of HIV and HCV cases were identified during the Roka outbreak in 2014-2015
- Group 2: subjects living in the other 4 villages of the Roka commune (Ta Haen I and II, Pou Batdambang, and Chhung Tradak)
- Group 3: subjects living in selected villages from Prey Khpos commune belonging to the Battambang Province.
- Specific objectives
Given the results we obtained during the investigation of the Roka nosocomial outbreak (2014-15), specific objectives are defined as follows:
- Risk of geographical spread of clustered HCV strains from Roka or Ambaeng Thngae villages to other villages of the Roka commune
- Risk of geographical spread of clustered HIV strains from Roka or Ambaeng Thngae villages to other villages of the Roka commune if the HIV prevalence of Group 2 and/or Group 3 is higher or equal to 0.7% (upper limit of confidence interval of HIV prevalence estimated in Cambodia).
- Comparison of unsafe injection and/or medical practices between the three groups
Methodology This cross-sectional survey will be conducted prospectively in 2 communes in the Battambang Province, i.e. the Roka commune and Prey Khpos commune of the Battambang province. A total of 1,098 eligible residents will be selected according to a three-stage cluster sampling method conducted in the selected sites. A structure questionnaire will assess the medical injection practices through a face-to-face interview. The study will be conducted into two steps. The first step will be a prevalence study to assess HIV and HCV prevalence rates in three groups of subject; Group 1: subjects living in Roka and Ambaeng Thngae villages where most of HIV and HCV cases were identified during the Roka outbreak; Group 2: subjects living in the other 4 villages of the Roka commune (Ta Haen I and II, Pou Batdambang, and Chhung Tradak) and Group 3: subjects living in villages from Prey Khpos commune belonging to the Battambang Province.
The second step will be the phylogenetic study of HIV. The phylogenetic study of HIV will be performed ONLY if HIV prevalence rates among group 2 and/or group 3 is higher or equal to 0.7% (upper limit of confidence interval of HIV prevalence estimated in Cambodia). If the result of HIV prevalence rates among group 2 and group 3 is lower or equal to 0.6% (HIV prevalence estimated in Cambodia), the phylogenetic study of HIV will NOT be performed.
A blood test will be done for HIV and HCV serological antibody screening. For the participants known as HIV positive and/or under ART treatment with NCHADS or as HCV positive, HCV and/or HIV antibody test will not be repeated for these participants and they will be considered as HCV and/or HIV positive. All individuals who will test positive for HCV will be further assessed for viral load measurements. In case of detectable VL results in plasma HCV strains will be amplified, sequenced, and characterized.
In the second step, all individuals who will test positive for HIV will be further assessed for viral load measurements. In case of detectable VL results in plasma or by using whole blood and/or peripheral blood mononuclear cells (PBMCs) in case of undetectable plasma HIV-1 RNA VL results, viral HIV strains will be amplified, sequenced, and characterized.
All tested participants will get a referral slip to retrieve their results (or those from their child) at health care center in the coverage area. Result disclosure will be provided by the doctor (or midwife or nurse) in each center. In case of positive result for at least one virus, we'll advice for the spouse to be tested as well. The same will be suggested for mothers and/or fathers whose child will be identified as infected. The transportation fee for this referral will be offered by the survey.
The total duration of this survey is expected to be 12 months.
Estimated enrollment 1,098 participants
Statistical methods
- Sample size The formula for two-group comparison was used to calculate the sample size, taking into account the design effect and refusal rate. The minimum sample size of 366 is required per group. Therefore, the total sample size for the 3 groups of subjects in the 2 communes in Battambang will be 1,098 individuals.
- Sampling strategies A three-stage cluster sampling method will be used to select the eligible participants among residents in the 2 communes in Battambang. This sampling method will be done according to three steps. First, we will select Roka and Prey Khpos Khpos commune in the Battambang province (a commune that looks alike Roka in terms of number of inhabitants is selected). Second, the Simple Random sampling will be used to select 1414 clusters (which are groups) for each group of study population. Third, simple random sampling strategy will be used to select 26 households from each cluster (group) and only one person will be selected per household. The next adjacent household will be used if the person is not present after 3 visits in the first visited household. If more than one person occupies the visited household, one participant will be randomly selected for blood test and face-to-face interview with the research team. If the selected participant is a child, the face-to-face interviews will be done with parent/legal guardian.
- Data analysis plan
Data analyses will include:
- Description of the participants' demographic characteristics,
- Comparison of HIV and HCV prevalence rates in 3 different groups (subjects living in Roka and Ambaeng Thngae villages of Roka commune, individuals living in the other 4 villages of the Roka commune, and people living in other villages of Prey Khpos commune in the Battambang) using Chi-squared test,
- Comparison of injection history in subjects living in Roka and Ambaeng Thngae villages of Roka versus residents from other villages using Chi-squared test,
- Comparison of viral strains circulating in Roka and Ambaeng Thngae villages of Roka commune versus those present in other villages.
Finally, multiple logistic regression models will be used to assess the independence of variables. All statistical analysis will be performed using STATA version 13.1 software (StataCorp LP, College Station, USA).
Survey timetable Survey start date: Second semester of 2019 Enrolment period: 2 months Subject participation duration: Cross-sectional study Total survey duration: 12 months Estimated survey/trial completion date: Second semester of 2020
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Three groups of subject will be selected: Group 1: subjects living in Roka and Ambaeng Thngae villages where most of HIV and HCV cases were identified during the Roka outbreak; Group 2: subjects living in the other 4 villages of the Roka commune (Ta Haen I and II, Pou Batdambang, and Chhung Tradak) and Group 3: subjects living in villages from Prey Khpos commune belonging to the Battambang Province. The minimum sample size of 366 is required per group. Therefore, the total sample size for the 3 groups of subjects will be 1,098 individuals.
Key inclusion criteria (4 listed)
- Children aged from 18 months to 14 years old
- Adult aged ≥ 15 years old
- Informed consent from the participant/parents
- Resident from the selected villages
Key exclusion criteria (1 listed)
- Children aged less than 18 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of HIV and HCV prevalence rates in 2 communes in Battambang province, as well as basic epidemiological risk factors associated with HIV and HCV infections.
Time frame: July 2019-December 2020
For the initial screening, ELISA techniques (Murex) will be used for HIV and HCV antibody (Ab) testing. In case of Ab positivity (for HIV and HCV), VL testing will be performed using the Biocentric HIV RNA assay, and the Omunis HCV RNA Viral Load technique. In case of detectable (>1,000 copies/ml) HIV and/or HCV VL results or using peripheral blood mononuclear cells (PBMCs) and/or DBS in case of undetectable plasma HIV-1 RNA VL results, viral strains will be amplified and sequenced by Macrogen as follows: C2V3 env region for HIV, and NS5B gene for HCV. The phylogenetic analyses will be done for HCV and for HIV using maximum likelihood tree inference and Bayesian evolutionary analyses to obtain temporal information about the date of origin and age of strains (according to 'molecular clock' approaches). Phylogenetic analysis will be performed with the MEGA6 and BEAST softwares.
1 secondary outcome
2/ Phylogenetic characterization of HCV strains circulating in these areas. 3/ Assessment of injection practices among tested subjects enrolled from the 2 studied communes.
Time frame: July 2019-December 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
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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.
Vonthanak SAPHONN principal investigator
University of Health Sciences, Cambodia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Seropositivity and HCV Infection, run by ANRS, Emerging Infectious Diseases at 1 site in Cambodia.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cambodia. 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?
Results are not available in the source record.
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?
Determination of HIV and HCV prevalence rates in 2 communes in Battambang province, as well as basic epidemiological risk factors associated with HIV and HCV infections. (time frame: July 2019-December 2020). 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 22 Oct 2019.