MHealth Intervention of HIV and STDs Partner Notification for MSM

HIV/AIDS Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04349748
• Other study ID #: NIDD-HIV
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2020
• Source: National Institute on Drug Dependence, China
• Contact: Zhongwei Jia, Prof. PhD
• Phone: +86-10-82802457
• Email: urchinjj[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6172
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV/AIDS
• Prevention
• Sexually Transmitted Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Dependence, China	Man Wellness Center, Beijing, China

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Guidelines on HIV Self-Testing and Partner Notification: Supplement to Consolidated Guidelines on HIV Testing Services. Geneva, Switzerland: World Health Organization; 2016 Dec.