HIV/AIDSNCT04349748
MHealth Intervention of HIV and STDs Partner Notification for MSM
A study testing Health education, and regular HIV and STDs testing prompting service and Health status inquiry through app (partner notification) in people with HIV/AIDS and Sexually Transmitted Diseases, run by National Institute on Drug Dependence, China.
Trial summary
Men who have sex with men (MSM) have become a focus of HIV and other sexually transmitted diseases (STD) control in China. Most of MSM who seek causal partners through online dating platforms do not know their sexual partners' real HIV and STDs infection status, which leads to more high risk status, especially for… Read more about this study
- Who is it for?
- Ages 15 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Sexually Transmitted Diseases, Prevention
- What is being tested?
- Health education, and regular HIV and STDs testing prompting service and Health status inquiry through app (partner notification)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,172 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 30 Jun 2023
- Phase
- Interventional
- 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 15 years and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- biologically male,
- had oral or anal sex with men at least once during their lifetime,
- 15 years of age or older,
- had no difficulty using a mobile phone,
- willing to provide their mobile phone numbers to serve as the unique identification numbers of the app's self-query and partner notification functions,
- willing to use the app's function modules,
Show all 9Show fewer
- willing to complete the questionnaire for the research,
- willing to continuously receive HIV and STDs testing and consulting services provided by the CBO our research setting at,
- willing to complete the informed consent document.
Who cannot join
- 1.had serious physical disabilities or mental diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Providing mHealth Intervention of Partner Notification to Protect MSM From HIV and Sexually Transmitted Diseases Infection: a Pragmatic Stepped Wedge Cluster Randomized Controlled Trial
Men who have sex with men (MSM) have become a focus of HIV and other sexually transmitted diseases (STD) control in China. Most of MSM who seek causal partners through online dating platforms do not know their sexual partners' real HIV and STDs infection status, which leads to more high risk status, especially for sexual behaviors. Effective Internet-based partner notification is urgently warranted to increase their risk awareness and prevent HIV and STDs transmission. This study developed an app which can help MSM to query recent HIV and other STDs statuses each other from the testing platform in order that they can find a relatively safety sexual partners and reduce risk of HIV infection.
Read the detailed description
Because most of the recent "Partner Notification" methods are a kind of afterwards remedial measures and will fail to find some of the infected MSM, researchers propose a preventive measures before they meet together. For MSM who are seeking potential sexual partners through Internet, researchers will encourage them to query health status before they decide to meet each other in order to promote their healthy self-responsibility consciousnes including avoiding HIV and other STDs infection, which will form a real ,digital MSM cohort. Researchers designed a pragmatic stepped wedge cluster randomized controlled trial to evaluate the effect of an intervention paradigm that provides HIV, syphilis, hepatitis B, and hepatitis C status partner notification based on the existing HIV and STDs control methods through an mHealth application (app), to reduce HIV and STDs incidences among MSM in China. More than 6000 MSM of 16 districts in Beijing, China will be grouped into four arms, each arm will cover four indepednent districts of Beijing randomly. The four arms will be randomized to sequentially initiate partner notification intervention through the app at 6-month intervals. All participants will be provided informed consent in the app after a full explanation of the protocol design. Researchers expect that the HIV incidence will be significantly lower and the secondary outcomes will also be better after partner notification intervention. The feasible and affordable public health management paradigm will have implications for HIV and STDs prevention and control among MSM and other key populations.
- Conditions
- HIV/AIDS, Sexually Transmitted Diseases, Prevention
- Being tested
- Health education, and regular HIV and STDs testing prompting service, Health status inquiry through app (partner notification)
- Keywords
- HIV/AIDS, sexually transmitted disease (STD), men who have sex with men (MSM), partner notification, mHealth application, stepped wedge cluster randomized controlled trial
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education, and regular HIV and STDs testing prompting serviceBehavioural
Health education through app for once a week, and regular HIV and STDs testing prompting service (every month through app) are given to the participants at the beginning of the study and last for the whole five observation periods.
Health status inquiry through app (partner notification)Behavioural
The permission to query health status through app (partner notification) is given to participants (participants can query their potential sexual partner's status of HIV, syphilis, hepatitis B, and hepatitis C respectively through app) at the specific observation period,and the permission is retained until the end of study.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | The group is given health education, regular HIV and STDs testing prompting service in the whole study, and permission to query health status (partner notification) through app from the second observation period. HIV and STDs testing and questionnaire are given to the participants when they receive the testing service. Receives: Behavioral: Health education, and regular HIV and STDs testing prompting service; Behavioral: Health status inquiry through app (partner notification) |
| Group 2 | Experimental | The group is given health education, regular HIV and STDs testing prompting service in the whole study, and permission to query health status (partner notification) through app from the third observation period. HIV and STDs testing and questionnaire are given to the participants when they receive the testing service. Receives: Behavioral: Health education, and regular HIV and STDs testing prompting service; Behavioral: Health status inquiry through app (partner notification) |
| Group 3 | Experimental | The group is given health education, regular HIV and STDs testing prompting service in the whole study, and permission to query health status (partner notification) through app from the fourth observation period. HIV and STDs testing and questionnaire are given to the participants when they receive the testing service. Receives: Behavioral: Health education, and regular HIV and STDs testing prompting service; Behavioral: Health status inquiry through app (partner notification) |
| Group 4 | Experimental | The group is given health education, regular HIV and STDs testing prompting service in the whole study, and permission to query health status (partner notification) through app from the fifth observation period. HIV and STDs testing and questionnaire are given to the participants when they receive the testing service. Receives: Behavioral: Health education, and regular HIV and STDs testing prompting service; Behavioral: Health status inquiry through app (partner notification) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV positive seroconversion rate (HIV incidence)
The number of HIV positive seroconversions divided by the total number of person-years.
Measured: through study completion, an average of six months
Additional cost of the intervention
The total cost and average cost for per participant of the integrated intervention model and each additional intervention/service based on the existing HIV prevention measures provided as before.
Measured: through study completion, an average of six months
Secondary outcomes (14)
Syphilis positive seroconversion rate (Syphilis incidence)
The number of syphilis seroconversions divided by the total number of person-years.
Measured: through study completion, an average of six months
Hepatitis B positive seroconversion rate (Hepatitis B incidence)
The number of hepatitis B seroconversions divided by the total number of person-years.
Measured: through study completion, an average of six months
Hepatitis C positive seroconversion rate (Hepatitis C incidence)
The number of hepatitis C seroconversions divided by the total number of person-years.
Measured: through study completion, an average of six months
HIV and related diseases transmission among social networks
Based on the partner notification information, we will construct the transmission networks of HIV and other STDs (syphilis, hepatitis B, and hepatitis C) among participants, and analyze the characteristics of these networks and factors associated with transmission of these diseases.
Measured: through study completion, an average of 1 year
Testing adherence
The proportion of participants whose every adjacent testing interval is no more than 3 months as recommended by China CDC.
Measured: through study completion, an average of 1 year
Additional cost for finding per seroconversion
The total additional cost of the integrated intervention model based on the existing HIV prevention measures provided as before divided by the total number of the HIV and STDs seroconversions.
Measured: through study completion, an average of six months
Frequency of utilization for each intervention/service
The total frequency and average frequency for per participant of utilization for each intervention/service, such as health education, partner notification, HIV and STDs testing and so on.
Measured: through study completion, an average of six months
Satisfaction of the interventions and services
This indicator is measured by the follow-up questionnaires as the degree of satisfaction for participants of HIV and STDs testing service, health education, partner notification and other app's functions.
Measured: through study completion, an average of six months
Knowledge of HIV and related STDs
This indicator is measured by the baseline and follow-up questionnaires, and we use the score of knowledge questions in the questionnaires to represent participants' level of knowledge.
Measured: through study completion, an average of six months
Attitudes of HIV and STDs testing, safe sexual behaviors and partner notification
The attitudes are collected by these questions in the baseline and follow-up questionnaires.
Measured: through study completion, an average of six months
Sexual behaviors
They are measured by questionnaires, including questions about the number of different kinds of sexual partners, frequency of anal sex, condom use, and partner notification implementation.
Measured: through study completion, an average of six months
Substance use behaviors
This indicator is measured by questionnaires about participants' usage about methamphetamine, heroin, ecstasy, and some other sex-promoting drugs.
Measured: through study completion, an average of six months
Psychological status
SAS (self-rating anxiety) scale and SDS (self-rating depression) scale are used to measure participants' psychological status through questionnaires. The higher scores of the two scares mean the worse outcomes.
Measured: through study completion, an average of six months
Referral rate of HIV and related STDs
The proportion of new HIV and STDs infections who have received treatment.
Measured: through study completion, an average of six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Jul 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is not a conventional crossover design,we use a pragmatic stepped-wedge cluster-randomised design.The study lasts for 2.5 years, which is divided to five continuous observation periods (every six months).The sixteen districts are assigned to four arms randomly.Four arms began recruiting participants at the same time,and at the first observation period,all groups were given health education and regular HIV and STDs testing prompting service,the two services above are given continuously for five observation periods.At the second observation period,the first group is given permission to query health status (partner notification) through app,but the other three groups do not.At every observation period after that (the third to fifth observation period),the three groups will be given permission to query health status one by one.Once a group is given the permission,it is retained until the end of study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6,172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Dependence, China
- Sponsor type
- University, hospital or other
- Collaborators
- Man Wellness Center, Beijing, China
- Responsible party
- Principal investigator, ZhongweiJia, National Institute on Drug Dependence, China
- Investigators
- Zhongwei Jia, Prof. PhD, Principal investigator, National Institute on Drug Dependence, Peking University,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349748
- Sponsor's protocol ID
- NIDD-HIV
- Status last verified
- May 2020
- First submitted
- 10 Apr 2020
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. Study Protocol,part of study report and data will be published in journals; 2. Researchers can contact the principal investigator(PI:ZhongweiJia) for IPD through email two years after the end of the trial.
Publications
Brown LB, Miller WC, Kamanga G, Nyirenda N, Mmodzi P, Pettifor A, Dominik RC, Kaufman JS, Mapanje C, Martinson F, Cohen MS, Hoffman IF. HIV partner notification is effective and feasible in sub-Saharan Africa: opportunities for HIV treatment and prevention. J Acquir Immune Defic Syndr. 2011 Apr 15;56(5):437-42. doi: 10.1097/qai.0b013e318202bf7d.
PubMed 22046601Tsega A, Udeagu CC, Begier EM. A comparison of partner notification effectiveness in African-, Caribbean-, and United States-born HIV-infected Blacks in New York City. AIDS Patient Care STDS. 2012 Jul;26(7):406-10. doi: 10.1089/apc.2011.0313. Epub 2012 Jun 4.
PubMed 22663166Rosenberg NE, Mtande TK, Saidi F, Stanley C, Jere E, Paile L, Kumwenda K, Mofolo I, Ng'ambi W, Miller WC, Hoffman I, Hosseinipour M. Recruiting male partners for couple HIV testing and counselling in Malawi's option B+ programme: an unblinded randomised controlled trial. Lancet HIV. 2015 Nov;2(11):e483-91. doi: 10.1016/S2352-3018(15)00182-4. Epub 2015 Oct 22.
PubMed 26520928Yan X, Lu Z, Zhang B, Li Y, Tang W, Zhang L, Jia Z. Protecting Men Who Have Sex With Men From HIV Infection With an mHealth App for Partner Notification: Observational Study. JMIR Mhealth Uhealth. 2020 Feb 19;8(2):e14457. doi: 10.2196/14457.
PubMed 32130147Yan X, Li Y, Su H, Xing Y, Zhang B, Lu Z, Jia Z. Protect MSM from HIV and other sexually transmitted diseases by providing mobile health services of partner notification: protocol for a pragmatic stepped wedge cluster randomized controlled trial. BMC Public Health. 2020 Jul 14;20(1):1107. doi: 10.1186/s12889-020-09162-x.
PubMed 32664934
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Providing mHealth Intervention of Partner Notification to Protect MSM From HIV and Sexually Transmitted Diseases Infection: a Pragmatic Stepped Wedge Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04349748
- Acronym / sponsor ID
- NIDD-HIV
- Conditions
- HIV/AIDS, Sexually Transmitted Diseases, Prevention
- Keywords
- HIV/AIDS, sexually transmitted disease (STD), men who have sex with men (MSM), partner notification, mHealth application, stepped wedge cluster randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,172 participants (estimated)
- Lead sponsor
- National Institute on Drug Dependence, ChinaUniversity, hospital or other
- Collaborators
- Man Wellness Center, Beijing, China
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 16 Apr 2020 (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.
Men who have sex with men (MSM) have become a focus of HIV and other sexually transmitted diseases (STD) control in China. Most of MSM who seek causal partners through online dating platforms do not know their sexual partners' real HIV and STDs infection status, which leads to more high risk status, especially for sexual behaviors. Effective Internet-based partner notification is urgently warranted to increase their risk awareness and prevent HIV and STDs transmission. This study developed an app which can help MSM to query recent HIV and other STDs statuses each other from the testing platform in order that they can find a relatively safety sexual partners and reduce risk of HIV infection.
Detailed description
Because most of the recent "Partner Notification" methods are a kind of afterwards remedial measures and will fail to find some of the infected MSM, researchers propose a preventive measures before they meet together. For MSM who are seeking potential sexual partners through Internet, researchers will encourage them to query health status before they decide to meet each other in order to promote their healthy self-responsibility consciousnes including avoiding HIV and other STDs infection, which will form a real ,digital MSM cohort. Researchers designed a pragmatic stepped wedge cluster randomized controlled trial to evaluate the effect of an intervention paradigm that provides HIV, syphilis, hepatitis B, and hepatitis C status partner notification based on the existing HIV and STDs control methods through an mHealth application (app), to reduce HIV and STDs incidences among MSM in China. More than 6000 MSM of 16 districts in Beijing, China will be grouped into four arms, each arm will cover four indepednent districts of Beijing randomly. The four arms will be randomized to sequentially initiate partner notification intervention through the app at 6-month intervals. All participants will be provided informed consent in the app after a full explanation of the protocol design. Researchers expect that the HIV incidence will be significantly lower and the secondary outcomes will also be better after partner notification intervention. The feasible and affordable public health management paradigm will have implications for HIV and STDs prevention and control among MSM and other key populations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- This study is not a conventional crossover design,we use a pragmatic stepped-wedge cluster-randomised design.The study lasts for 2.5 years, which is divided to five continuous observation periods (every six months).The sixteen districts are assigned to four arms randomly.Four arms began recruiting participants at the same time,and at the first observation period,all groups were given health education and regular HIV and STDs testing prompting service,the two services above are given continuously for five observation periods.At the second observation period,the first group is given permission to query health status (partner notification) through app,but the other three groups do not.At every observation period after that (the third to fifth observation period),the three groups will be given permission to query health status one by one.Once a group is given the permission,it is retained until the end of study.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Health education, and regular HIV and STDs testing prompting service, Behavioral: Health status inquiry through app (partner notification)The group is given health education, regular HIV and STDs testing prompting service in the whole study, and permission to query health status (partner notification) through app from the second observation period. HIV and STDs testing and questionnaire are given to the participants when they receive the testing service. |
| Group 2 | Experimental | Behavioral: Health education, and regular HIV and STDs testing prompting service, Behavioral: Health status inquiry through app (partner notification)The group is given health education, regular HIV and STDs testing prompting service in the whole study, and permission to query health status (partner notification) through app from the third observation period. HIV and STDs testing and questionnaire are given to the participants when they receive the testing service. |
| Group 3 | Experimental | Behavioral: Health education, and regular HIV and STDs testing prompting service, Behavioral: Health status inquiry through app (partner notification)The group is given health education, regular HIV and STDs testing prompting service in the whole study, and permission to query health status (partner notification) through app from the fourth observation period. HIV and STDs testing and questionnaire are given to the participants when they receive the testing service. |
| Group 4 | Experimental | Behavioral: Health education, and regular HIV and STDs testing prompting service, Behavioral: Health status inquiry through app (partner notification)The group is given health education, regular HIV and STDs testing prompting service in the whole study, and permission to query health status (partner notification) through app from the fifth observation period. HIV and STDs testing and questionnaire are given to the participants when they receive the testing service. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- biologically male,
- had oral or anal sex with men at least once during their lifetime,
- 15 years of age or older,
- had no difficulty using a mobile phone,
- willing to provide their mobile phone numbers to serve as the unique identification numbers of the app's self-query and partner notification functions,
Key exclusion criteria (1 listed)
- 1.had serious physical disabilities or mental diseases.
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 |
|---|---|---|
| Health education, and regular HIV and STDs testing prompting serviceHealth education through app for once a week, and regular HIV and STDs testing prompting service (every month through app) are given to the participants at the beginning of the study and last for the whole five observation periods. | Behavioural | Group 1, Group 2, Group 3, Group 4 |
| Health status inquiry through app (partner notification)The permission to query health status through app (partner notification) is given to participants (participants can query their potential sexual partner's status of HIV, syphilis, hepatitis B, and hepatitis C respectively through app) at the specific observation period,and the permission is retained until the end of study. | Behavioural | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
HIV positive seroconversion rate (HIV incidence)
Time frame: through study completion, an average of six months
The number of HIV positive seroconversions divided by the total number of person-years.
Additional cost of the intervention
Time frame: through study completion, an average of six months
The total cost and average cost for per participant of the integrated intervention model and each additional intervention/service based on the existing HIV prevention measures provided as before.
14 secondary outcomes
Syphilis positive seroconversion rate (Syphilis incidence)
Time frame: through study completion, an average of six months
Hepatitis B positive seroconversion rate (Hepatitis B incidence)
Time frame: through study completion, an average of six months
Hepatitis C positive seroconversion rate (Hepatitis C incidence)
Time frame: through study completion, an average of six months
HIV and related diseases transmission among social networks
Time frame: through study completion, an average of 1 year
Testing adherence
Time frame: through study completion, an average of 1 year
Additional cost for finding per seroconversion
Time frame: through study completion, an average of six months
Frequency of utilization for each intervention/service
Time frame: through study completion, an average of six months
Satisfaction of the interventions and services
Time frame: through study completion, an average of six months
Knowledge of HIV and related STDs
Time frame: through study completion, an average of six months
Attitudes of HIV and STDs testing, safe sexual behaviors and partner notification
Time frame: through study completion, an average of six months
Sexual behaviors
Time frame: through study completion, an average of six months
Substance use behaviors
Time frame: through study completion, an average of six months
Psychological status
Time frame: through study completion, an average of six months
Referral rate of HIV and related STDs
Time frame: through study completion, an average of six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Background: PubMed 22046601Brown LB, Miller WC, Kamanga G, Nyirenda N, Mmodzi P, Pettifor A, Dominik RC, Kaufman JS, Mapanje C, Martinson F, Cohen MS, Hoffman IF. HIV partner notification is effective and feasible in sub-Saharan Africa: opportunities for HIV treatment and prevention. J Acquir Immune Defic Syndr. 2011 Apr 15;56(5):437-42. doi: 10.1097/qai.0b013e318202bf7d.
- Background: PubMed 22663166Tsega A, Udeagu CC, Begier EM. A comparison of partner notification effectiveness in African-, Caribbean-, and United States-born HIV-infected Blacks in New York City. AIDS Patient Care STDS. 2012 Jul;26(7):406-10. doi: 10.1089/apc.2011.0313. Epub 2012 Jun 4.
- Background: PubMed 26520928Rosenberg NE, Mtande TK, Saidi F, Stanley C, Jere E, Paile L, Kumwenda K, Mofolo I, Ng'ambi W, Miller WC, Hoffman I, Hosseinipour M. Recruiting male partners for couple HIV testing and counselling in Malawi's option B+ programme: an unblinded randomised controlled trial. Lancet HIV. 2015 Nov;2(11):e483-91. doi: 10.1016/S2352-3018(15)00182-4. Epub 2015 Oct 22.
- Background: PubMed 32130147Yan X, Lu Z, Zhang B, Li Y, Tang W, Zhang L, Jia Z. Protecting Men Who Have Sex With Men From HIV Infection With an mHealth App for Partner Notification: Observational Study. JMIR Mhealth Uhealth. 2020 Feb 19;8(2):e14457. doi: 10.2196/14457.
- Derived from this study: PubMed 32664934Yan X, Li Y, Su H, Xing Y, Zhang B, Lu Z, Jia Z. Protect MSM from HIV and other sexually transmitted diseases by providing mobile health services of partner notification: protocol for a pragmatic stepped wedge cluster randomized controlled trial. BMC Public Health. 2020 Jul 14;20(1):1107. doi: 10.1186/s12889-020-09162-x.
- Individual participant dataSharing planned: Yes. 1. Study Protocol,part of study report and data will be published in journals; 2. Researchers can contact the principal investigator(PI:ZhongweiJia) for IPD through email two years after the end of the trial.
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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.
Zhongwei Jia, Prof. PhD principal investigator
National Institute on Drug Dependence, Peking University,China
Questions about this trial
What is this clinical trial studying?
A study testing Health education, and regular HIV and STDs testing prompting service and Health status inquiry through app (partner notification) in people with HIV/AIDS and Sexually Transmitted Diseases, run by National Institute on Drug Dependence, 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 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 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Zhongwei Jia, Prof. PhD (+86-10-82802457, urchinjj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV positive seroconversion rate (HIV incidence) (time frame: through study completion, an average of six 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?
On the ClinicalTrials.gov record for NCT04349748, which also lists 5 linked publications.
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 27 May 2020.