Clinical trial NCT04349748: MHealth Intervention of HIV and STDs Partner Notification for MSM
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: National Institute on Drug Dependence, China
Sponsor class: OTHER
Collaborators: name: Man Wellness Center, Beijing, China
First posted: 2020-04-16
Enrollment: 6172
Sex: MALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: HIV positive seroconversion rate (HIV incidence)
timeFrame: through study completion, an average of six months
measure: Additional cost of the intervention
timeFrame: through study completion, an average of six months
Secondary outcomes:
measure: Syphilis positive seroconversion rate (Syphilis incidence)
timeFrame: through study completion, an average of six months
measure: Hepatitis B positive seroconversion rate (Hepatitis B incidence)
timeFrame: through study completion, an average of six months
measure: Hepatitis C positive seroconversion rate (Hepatitis C incidence)
timeFrame: through study completion, an average of six months
measure: HIV and related diseases transmission among social networks
timeFrame: through study completion, an average of 1 year
measure: Testing adherence
timeFrame: through study completion, an average of 1 year
measure: Additional cost for finding per seroconversion
timeFrame: through study completion, an average of six months
measure: Frequency of utilization for each intervention/service
timeFrame: through study completion, an average of six months
measure: Satisfaction of the interventions and services
timeFrame: through study completion, an average of six months
measure: Knowledge of HIV and related STDs
timeFrame: through study completion, an average of six months
measure: Attitudes of HIV and STDs testing, safe sexual behaviors and partner notification
timeFrame: through study completion, an average of six months
measure: Sexual behaviors
timeFrame: through study completion, an average of six months
measure: Substance use behaviors
timeFrame: through study completion, an average of six months
measure: Psychological status
timeFrame: through study completion, an average of six months
measure: Referral rate of HIV and related STDs
timeFrame: through study completion, an average of six months
Other outcomes:
Locations:
Study officials:
affiliation: National Institute on Drug Dependence, Peking University,China
name: Zhongwei Jia, Prof. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.