MHealth Intervention of HIV and STDs Partner Notification for MSM

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sexually Transmitted Diseases; HIV/AIDS; Prevention
• Intervention / Treatment: Behavioral: Health education, and regular HIV and STDs testing prompting service; Behavioral: Health status inquiry through app (partner notification)

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 Type: Interventional
• Enrollment (Anticipated): 6172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhongwei Jia, Prof. PhD; Phone Number: +86-10-82802457; Email: urchinjj@163.com
• Study Contact Backup: Name: Xiangyu Yan, PhD; Phone Number: +86-18380205261; Email: yanxiangyu@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion criteria:

1. biologically male,
2. had oral or anal sex with men at least once during their lifetime,
3. 15 years of age or older,
4. had no difficulty using a mobile phone,
5. willing to provide their mobile phone numbers to serve as the unique identification numbers of the app's self-query and partner notification functions,
6. willing to use the app's function modules,
7. willing to complete the questionnaire for the research,
8. willing to continuously receive HIV and STDs testing and consulting services provided by the CBO our research setting at,
9. willing to complete the informed consent document.

Exclusion criteria:

1.had serious physical disabilities or mental diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; 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.	Behavioral: Health education, and regular HIV and STDs testing prompting service; 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.; Behavioral: 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.
Experimental: Group 2; 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.	Behavioral: Health education, and regular HIV and STDs testing prompting service; 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.; Behavioral: 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.
Experimental: Group 3; 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.	Behavioral: Health education, and regular HIV and STDs testing prompting service; 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.; Behavioral: 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.
Experimental: Group 4; 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.	Behavioral: Health education, and regular HIV and STDs testing prompting service; 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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV positive seroconversion rate (HIV incidence)	The number of HIV positive seroconversions divided by the total number of person-years.	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.	through study completion, an average of six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Syphilis positive seroconversion rate (Syphilis incidence)	The number of syphilis seroconversions divided by the total number of person-years.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	through study completion, an average of six months

Collaborators and Investigators

• Sponsor: National Institute on Drug Dependence, China
• Collaborators: Man Wellness Center, Beijing, China
• Investigators: Principal Investigator: Zhongwei Jia, Prof. PhD, National Institute on Drug Dependence, Peking University,China

Publications and helpful links

General 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.
• Tsega 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.
• Rosenberg 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.
• Yan 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.
• Yan 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.

Helpful Links

• NCAIDS, NCSTD, China CDC. Guidelines on HIV/AIDS Prevention Interventions for Men Who Have Sex With Men. 2016.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 25, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: partner notification; HIV/AIDS; mHealth application; sexually transmitted disease (STD); men who have sex with men (MSM); stepped wedge cluster randomized controlled trial
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases
• Other Study ID Numbers: NIDD-HIV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol,part of study report and data will be published in journals;; Researchers can contact the principal investigator(PI:ZhongweiJia) for IPD through email two years after the end of the trial.
• IPD Sharing Time Frame: Two years after the end of the trial
• IPD Sharing Access Criteria: Data applicants should send email to PI. Real personal basic information (name, unit, title, etc.), detailed description of required data (required variables,etc.), and research plan should be included in the email. Our team will discuss the research proposal and reply as soon as possible
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No