Background
Men who have sex with men (MSM) have been identified as high risk population of HIV infection and transmission since the world’s first AIDS case found in the United States at 1981 [
1], and studies about HIV prevention among MSM had not been paid enough attention by Chinese researchers until the first case of AIDS patient in China found at 1985 [
2]. HIV prevalence among MSM population has been continuously increasing at a rapid speed [
3,
4]. In China, the proportion of HIV infection among MSM population jumped from 1.4% in 2001 to 6.3% in 2011 [
5]. In 2007, MSM accounted for 12.2% among all of the yearly found new HIV infection cases, but this percentage soared to 29.4% in 2011 [
6]. And in Changsha, Hunan Province of China, 46% of the yearly found new HIV cases are MSM (Changsha CDC). MSM have become the key population of HIV prevention interventions.
Despite scientists’ ongoing efforts to explore biomedical techniques of HIV prevention such as vaccine development, circumcision, antiviral drug use and so forth [
7‐
9], behavioral interventions are still regarded as key approaches to HIV prevention [
10,
11]. These involve regularly HIV testing, free condom providing, health education (e.g. peer education), individual behavioral and mental health counseling [
12‐
17], etc. They have been proved to be effective of improving MSM’s health behaviors, finding newly infected individuals timely and referring them to rapid care and treatment services. Lots of existed studies involved an intervention package which consists of more than one way of behavioral intervention [
18,
19]. However, since most of the interventions were performed by face-to-face patterns, there were three limitations which may constrain their effects. (1) High financial cost, labor consumption, and time consuming, (2) narrow coverage of MSM group, and (3) unsatisfying intervention adherence [
20]. So it is imperative to explore more effective, extensively accessible, economic and comprehensive HIV prevention tools and strategies [
21].
The contemporary world has been greatly changed by the Internet. And the Internet supported interventions have been regarded as “
disruptive innovations” and become new weapons by researchers and health providers when it comes to HIV prevention [
22]. The internet-based interventions have 3 irreplaceable advantages over face-to-face delivered interventions, (1) these interventions can be broadly diffused and maintained at lower financial and personnel cost, (2) the Internet’s characteristics like anonymity and information confidentiality can improve acceptability of the interventions among MSM, (3) the interactive functionality of the Internet gains popularity among different populations, especially among those hard-to-reach groups [
23,
24].
Online surveys can provided us with a large amount of information about MSM’s sexual behaviors and mental health in a short period of time, giving auto reminders of HIV testing to clients, conducting motivational interviews about behavior changing and health skills promoting, and performing health education by using websites [
25‐
28]. Levine and colleagues developed an online partner notification system
inSPOT to inform sex partners of the HIV-positive person to take HIV test [
29]. In China, gay websites often be used as tools for health behavior collecting, education delivering, and as a recruiting method for intervention outreach to offline sites [
30‐
32]. Guangzhou CDC of China cooperated with a gay website named Guangtong website to develop a web platform named
Easy Tell to do anonymous partner notification [
33]. Effects of these Internet-based HIV prevention interventions were proved to be comparable to those face-to-face interventions, and they were more accessible and acceptable.
Mobile network is the combination of mobile communication devices and the Internet, mobile phone application(app) is the typical type and current trend of mobile network [
34]. Six-hundred fifty-six million Chinese are currently using mobile phones to link to the Internet [
35], and it is estimated that 6.72 to 16.8 million of them are MSM. Comparing with computer network, mobile network has more strength, especially with the users online almost 24/7, we can make the intervention to penetrate into the users daily lives. And because of the personal privacy of mobile phone, the intervention can be more targeted and individualized. Besides, personal behavioral data can be collected easily by mobile network due to its portability and access to sensing devices, the big data collected can be analyzed to explore the mechanism of the intervention, which previous studies cannot hold a candle to.
It was consumed that app-based interventions have great potential to become a vital window for health maintenance and promotion of MSM [
36]. Several qualitative studies conducted by MSM focus group discussions demonstrated preferences and functionality of HIV prevention app. The app should include educational content like information about HIV testing and prophylaxis distribution institutions and groups, HIV/STDs diagnose and treatment information, drug and alcohol abuse risk and safer sex skills. Interactive engagement such as connection with gay-friendly health providers, other HIV-positive gay men, and support peers/groups. Usability of the app is the most important feature because the app would not be of value if MSM do not use it, which means MSM feel useful, safe and trustworthy about the app’s language and confidentiality [
24,
37,
38]. Our previous studies found that mobile phones were widely used among MSM, it was popular for MSM using the gay tailored dating apps such as Grindr, Jack’D, and domestic apps like Blued, ZANK for speed dating, casual sex, or even group sex. Lots of Chinese MSM expressed urgent need of humanistic care, professional mental and behavioral health services, and welcome interventions using the app, Wechat and other mobile network media with open arms [
39,
40]. However, there is no MSM tailored, app-based HIV prevention emerged so far.
The objectives of the study are to (1) design and develop an easy to use, user-friendly, non-stigmatized and free app, and deliver app-based HIV prevention intervention to MSM, and (2) to evaluate the effectiveness of the app at decreasing rate of HIV infection, promoting HIV testing behavior and consistent condom use among MSM, and cost-effectiveness analysis of the intervention. App-based intervention mechanism will also be explored.
Participants
Inclusion and exclusion criteria
Participant inclusion criteria: (1) male aged 16 years or older, (2) has experience of same-sex anal intercourse during the last 12 months, (3) HIV negative, (4) own at least one smartphone, and (5) willing to report individual HIV/STDs testing results to the researcher. Participant exclusion criteria:(1) has only one sex partner who is also HIV negative, and their relationship has last for more than 2 years, (2) unable to participant the program because of cognitive or psychiatric disorders, or (3) has already attended another intervention program.
Recruitment
For the participant enrollment, in phase 1 and phase 2, MSM who are potential eligible for the study will be listed, and each individual will be invited to take free HIV testing and participate in the study through phone call performed by the staff of CDC and the two NGOs. An appointment will be made if the person agrees to participate. Following an oral informed consent, clients will be screened for eligibility as subjects of the study by a research member, demographic information and baseline data(details below) will be obtained, and blood samples will be taken for HIV testing. Written informed consent will be obtained from each one who is HIV-seronegtive and willing to participate in the study. Those HIV-seropositive persons will be referred to local CDC for verification and treatment.
Randomization and blinding
Participants in the randomized controlled trial will be assigned 1:1 to the intervention and control arms under restricted randomized block design (the block length is 4) after informed consent and collection of baseline data. The allocation sequence will be generated and released to the interventionist on a case-by-case basis by another independent department specializes in generating research random sequence. The recruitment staff have no access to the results of randomization prior to recruiting the subject. Participants will be informed of his group by a research assistant by phone. Interventionist, data collection staff, statistician are not the same persons. This is a single-blinded trial. The subjects cannot be blinded due to the nature of the intervention, and interventionist also acknowledge all those contacted are in the intervention arm. But anonymous responses will be entered into the database by a person unconnected with the project. The statistician will be blinded to individual result during the intervention period, and the allocation-to-trial-arm coding will not be revealed until dataset is sealed. The interventionist and supervisors will be blinded to the baseline and follow-up outcomes.
Discussion
In line with goals of implementation science, the study is going to develop a mobile phone app which comprises of behavioral, psychological and social services and for MSM, and implement a randomized controlled trial of HIV prevention intervention by using this app among MSM and evaluate effectiveness of the app-based intervention. The goals of the intervention are to provide MSM with health information, encourage their motivation of behavior change and promote their health skills.
It has been shown that apps are beneficial to self-management of people with chronic conditions, physical activity promotion among different age groups, and other health related behaviors [
44‐
46]. There were systematic reviews pointed out that apps have great potential as tools for HIV prevention among MSM, and there were also studies on MSM’s acceptability and preferences of app-based. However, there is no randomized controlled trial targeting at MSM group with an app. This is the first study of its kind.
There are several strengths of the study. Mobile network is the combination of the Internet and mobile devices, and has the advantage of higher portability. The “always online” feature made it become a part of one’s daily life. Mobile phone can protect personal privacy and realizes point-to-point individualized intervention as well, which provide us with a better and accurate way to illustrate intervention mechanism. The long-term follow-up makes it possible to observe intervention effects with more persuasive results. And the cost-effectiveness analysis will help policy makers perform informed and practical decision-making.
As for the limitations of the study design, due to the open design we cannot mask the intervention, participants will be aware that they are in a HIV prevention intervention, which may introduce bias. Randomization allocation of participants into different groups can help achieve balance in sociodemographic characteristics. And researcher in charge of statistical analysis will be blinded to group allocation.