HIV/AIDSNCT03860116
Evaluation of a Smart Phone App-based Case Management Model Among ART-naive HIV-infected MSM
A study testing APP-based case management service and Standard-of-care followup service in people with HIV/AIDS, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a randomized controlled trial about an app-based case management intervention. The intervention is a comprehensive case management approach consisting of the following aspects: articles delivery, online communication with case managers, supportive service information and hospital visits reminders. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- APP-based case management service and Standard-of-care followup service
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2019to Dec 2020
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. diagnosed as HIV positive;
- 2. initiate antiretroviral therapy on the day of recruitment;
- 3. was infected through male same-sex behavior;
- 4. has access to internet on a personal mobile phone;
- 5. has a Wechat account and use it daily;
- 6. willing to provide written informed consent;
Who cannot join
- 1. under severe physical or mental condition which precludes study participation;
- 2. being an inpatient of the hospital;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, 510080
Linghua Li, +86 13725297174, 870100302@qq.com
About this study
Official title: Development and Evaluation of a Smart Phone App-based Case Management Model Among ART-naive HIV-infected MSM： A Randomized Controlled Trial
This is a randomized controlled trial about an app-based case management intervention. The intervention is a comprehensive case management approach consisting of the following aspects: articles delivery, online communication with case managers, supportive service information and hospital visits reminders. The aim of this study is to evaluate the efficacy of the intervention among HIV-positive men who have sex with men compared to standard-of-care service.
Read the detailed description
Men who have sex with men (MSM) are one of the key populations in HIV epidemic. They are characterized by multiple risky sexual behaviors: unprotected anal/oral sex, commercial sex, sex during drug use and multiple partners sexual behavior. In the conservative context of Chinese culture, MSM face a wide variety of psychosocial barriers including: stigma, poor mental health and lack of social support. HIV-positive MSM, not only do they have to deal with external stress about their sexual preference, but they also face the pressure to hide their infection status to avoid discrimination. The aforementioned factors limit their adherence to antiretroviral treatment (ART), and lead to suboptimal treatment outcome. Besides, due to the ART scale-up strategy in China, the existing health system is burdened with increasing numbers of patients, which calls for innovative patient management approach using mobile technology. Moreover, the needs of HIV/AIDS patients are growing complex. So, case management, a comprehensive service model, is adopted to meet the needs of patients with chronic illness, combined with smart phone application (APP) to improve adherence of HIV-positive Chinese men who have sex with men.
This study aims to evaluate the efficacy of an APP-based case management approach on ART adherence. 600 participants will be recruited and randomized into intervention group or control group. The app is called "Trusted Doctor". It allows communication between doctor and patient as well as online patient management including: sharing disease related knowledge, scheduling follow up questionnaire to collect patients' information, visits reminder, free phone calls with phone numbers encrypted. In this study, doctors download the APP, and participants in the intervention group will use Wechat to follow the platform which is connected to Trusted Doctor. Inc server and receive intervention. Wechat is a popular social media that not only allows instant messaging between users, but also provides individuals or groups the function of delivering articles or messages on their own Wechat platform to subscribers. By establishing a unique Wechat platform and link it with the APP, service and relative information can be provided on the daily communication tool. After being screened and informed consent, eligible participants will administer a baseline questionnaire on a tablet and then be randomized into intervention or control group. An identification number will be generated for each participant in this study. Then the intervention group will use Wechat to follow the platform and add contact of case managers. Tutoring about the function of the platform will be provided by investigators. Intervention in this study includes: articles delivery, online communication with case managers, supportive service information and hospital visits reminders. Both the intervention and control group will receive standard-of-care service in the hospital, including medication education after treatment initiation, physical examination and brief counselling scheduled at each hospital visits. Hospital visits are scheduled at month 1/2/3/6/12. Questionnaires are scheduled at baseline, month 1, 3, 6, and 12. Follow-up questionnaires will be delivered through Wechat. The primary outcome is ART adherence and CD4+ T cell count.
- Conditions
- HIV/AIDS
- Being tested
- APP-based case management service, Standard-of-care followup service
- Keywords
- case management, men who have sex with men, mhealth
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APP-based case management serviceBehavioural
The intervention consists of 4 parts, educational articles, online communication with case managers, supportive service information and visit reminder. Educational articles are both delivered automatically and retrieved by participants. Online communication can also be initiated by participants and case managers. Case managers are request to respond to questions from participants as well as care about medication taking behaviors of each patients during the first month. Supportive service information, which include time, location and charges of service providers will be retrieved by participants, with reminders of available service information scheduled at the beginning of every month. Visit reminders are scheduled at one week before due date.
Standard-of-care followup serviceBehavioural
When participants initiate HIV antiretroviral treatment (ART), they receive 20-minute ART-related education from the case managers, and have physical examination including blood test, CD4 count, hepatic and renal function tests. Subsequent visits are scheduled at month 1, 2, 3, 6 and 12. During each visit, pills enough to cover days until the next visit will be distributed. And patients will be asked about their medication adherence, high risk behavior and side effects experienced. Any relevant questions from patients will be answered. Physical tests are also included in the routine of each visits.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | participants in this arm receive the APP-based case management service and standard-of-care followup service. Receives: Behavioral: APP-based case management service; Behavioral: Standard-of-care followup service |
| control group | Active comparator | participants in the control arm receive standard-of-care followup service Receives: Behavioral: Standard-of-care followup service |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported ART medication adherence
Measured by visual analogue scale (VAS) ranging from 0 to 100%. The ART medication visual analogue scale is a instrument for patients to rate their dose taken percentages. 100% of doses taken will be regarded as good adherence.
Measured: month 6 after enrolment
CD4 count
measured by flow cytometer during visits to hospitals
Measured: month 6 after enrolment
Secondary outcomes (7)
Anxiety
Reference： Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Archives of internal medicine 2006; 166(10):1092-1097.
Anxiety will be measured by Generalized Anxiety Disorder (GAD)-7, including 7 Likert-style items. Response options include "not at all", "several days", "more than half the days", "nearly every day". Scores of 0, 1, 2, and 3 will be assigned to the response categories, respectively. Cronbach's alpha was 0.92. Total score for the scale ranges from 0 to 21. Score will be categorized into 4 level to indicate anxiety level: minimal anxiety (0-4 points), mild anxiety (5-9 points), moderate anxiety (10-14), severe anxiety (15-21)
Measured: baseline and month 1/3/6/12 after enrolment
Depression
Reference: Kroenke K, Spitzer RL. The PHQ-9: A new depression diagnostic and severity measure. Psychiatric Annals 2002; 32(9):509-515.
The Patient Health Questionnaire (PHQ) -9 is a 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression. The total of all 9 responses from the PHQ-9 aims to predict the presence and severity of depression. Questions are about the level of interest in doing things, feeling down or depressed, difficulty with sleeping, energy levels, eating habits, self-perception, ability to concentrate, speed of functioning and thoughts of suicide. Responses range from "0" (Not at all) to "3" (nearly every day). A total sum of the responses suggests varying levels of depression. Scores range from 0 to 27. Scores of 10 or higher is suggestive of the presence of depression, with higher score indicating more severe level of depression.
Measured: baseline and month 1/3/6/12 after enrolment
Quality of Life
Reference: Pedroso B, Gutierrez GL, Duarte E, Pilatti LA, Picinin CT. Quality of life assessment in people living with HIV/AIDS: clarifying the WHOQOL-HIV and WHOQOL-HIV-Bref instruments. In: Global view of HIV infection: InTech; 2011.
The WHOQOL-HIV BREF is an abbreviated version instrument for evaluation of quality of life specifically designed for people with HIV or AIDS. It contains five extra items specific to PLWHA, and in total contains 31 items. Its items are rated on a 5-points Likert scale, and the available responses are 1 (not at all), 2 (a little) 3 (a moderate amount), 4 (very much) and 5 (an extreme amount). The WHOQOL-HIV BREF contains six domains (physical, psychological, independence, social relations, environment, spiritual/religion/person beliefs) and overall quality of life and general health perceptions. After reverse negatively phrased items, domains and facet scores are scaled in a positive direction where higher scores denote higher quality of life.
Measured: baseline and month 3/6/12 after enrolment
ART-related perception
Reference: The Life Windows Project Team. The Life Windows Information Motivation Behavioral Skills ART Adherence Questionnaire (LW-IMB-AAQ). 2006. Center for Health, Intervention, and Prevention. University of Connecticut.
The LW-IMB-AAQ was developed as a measure of barriers to antiretroviral therapy (ART)adherence among HIV+ patients in clinical care, following the constructs identified in the Information--Motivation--Behavioral Skills (IMB) model of adherence
The Information and Motivation subscale includes 19 and 10 Likert-style items, respectively. Response options include "Strongly Disagree", "Somewhat Disagree", "Neither Agree nor Disagree", "Somewhat Agree", and "Strongly Agree". Cronbach's alpha was 0.59 and 0.75 in a sample of youth living with HIV, respectively. Higher scores indicate greater knowledge and motivation of ART treatment.
This subscale includes 14 items. Cronbach's alpha was 0.90. Higher scores indicate greater motivation towards adherence.
Measured: baseline and month 1/3/6/12 after enrolment
High risk sexual behavior
measured by self-selected items including "how many male/female regular/casual partners did you engage in sexual intercourse with during the last month?" And "How frequent did you use condoms during sexual intercourses in the last month with your regular/casual partners?"
Measured: baseline and month 1/3/6/12 after enrolment
Retention in ART
kept and missed primary care visits record retrieved from hospital document
Measured: month 1/3/6/12 after enrolment
HIV RNA viral load
measured by polymerase chain reaction(PCR) during visits to hospitals
Measured: baseline and month 12 after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start19 Mar 2019
- Primary completionJun 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Eighth People's Hospital
- Responsible party
- Principal investigator, Gu Jing, Sun Yat-sen University
- Investigators
- Jing Gu, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860116
- Sponsor's protocol ID
- 2017A020212006
- Status last verified
- Oct 2019
- First submitted
- 14 Feb 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available from the principal investigator on reasonable request. Due to the highly sensitive nature of the data collected and the characteristics of this often stigmatized population, no client-level data will be shared until the entire cohort is accrued and completed, even that which is de-identified.
Publications
Fan X, Ning K, Liu C, Zhong H, Lau JTF, Hao C, Hao Y, Li J, Li L, Gu J. Uptake of an App-Based Case Management Service for HIV-Positive Men Who Have Sex With Men in China: Process Evaluation Study. J Med Internet Res. 2023 Apr 26;25:e40176. doi: 10.2196/40176.
PubMed 37099367Fan X, She R, Liu C, Zhong H, Lau JTF, Hao C, Li J, Hao Y, Li L, Gu J. Evaluation of smartphone APP-based case-management services among antiretroviral treatment-naive HIV-positive men who have sex with men: a randomized controlled trial protocol. BMC Public Health. 2020 Jan 20;20(1):85. doi: 10.1186/s12889-020-8171-5.
PubMed 31959139
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Smart Phone App-based Case Management Model Among ART-naive HIV-infected MSM： A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03860116
- Acronym / sponsor ID
- 2017A020212006
- Conditions
- HIV/AIDS
- Keywords
- case management, men who have sex with men, mhealth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Guangzhou Eighth People's Hospital
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 1 Mar 2019 (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.
This is a randomized controlled trial about an app-based case management intervention. The intervention is a comprehensive case management approach consisting of the following aspects: articles delivery, online communication with case managers, supportive service information and hospital visits reminders. The aim of this study is to evaluate the efficacy of the intervention among HIV-positive men who have sex with men compared to standard-of-care service.
Detailed description
Men who have sex with men (MSM) are one of the key populations in HIV epidemic. They are characterized by multiple risky sexual behaviors: unprotected anal/oral sex, commercial sex, sex during drug use and multiple partners sexual behavior. In the conservative context of Chinese culture, MSM face a wide variety of psychosocial barriers including: stigma, poor mental health and lack of social support. HIV-positive MSM, not only do they have to deal with external stress about their sexual preference, but they also face the pressure to hide their infection status to avoid discrimination. The aforementioned factors limit their adherence to antiretroviral treatment (ART), and lead to suboptimal treatment outcome. Besides, due to the ART scale-up strategy in China, the existing health system is burdened with increasing numbers of patients, which calls for innovative patient management approach using mobile technology. Moreover, the needs of HIV/AIDS patients are growing complex. So, case management, a comprehensive service model, is adopted to meet the needs of patients with chronic illness, combined with smart phone application (APP) to improve adherence of HIV-positive Chinese men who have sex with men.
This study aims to evaluate the efficacy of an APP-based case management approach on ART adherence. 600 participants will be recruited and randomized into intervention group or control group. The app is called "Trusted Doctor". It allows communication between doctor and patient as well as online patient management including: sharing disease related knowledge, scheduling follow up questionnaire to collect patients' information, visits reminder, free phone calls with phone numbers encrypted. In this study, doctors download the APP, and participants in the intervention group will use Wechat to follow the platform which is connected to Trusted Doctor. Inc server and receive intervention. Wechat is a popular social media that not only allows instant messaging between users, but also provides individuals or groups the function of delivering articles or messages on their own Wechat platform to subscribers. By establishing a unique Wechat platform and link it with the APP, service and relative information can be provided on the daily communication tool. After being screened and informed consent, eligible participants will administer a baseline questionnaire on a tablet and then be randomized into intervention or control group. An identification number will be generated for each participant in this study. Then the intervention group will use Wechat to follow the platform and add contact of case managers. Tutoring about the function of the platform will be provided by investigators. Intervention in this study includes: articles delivery, online communication with case managers, supportive service information and hospital visits reminders. Both the intervention and control group will receive standard-of-care service in the hospital, including medication education after treatment initiation, physical examination and brief counselling scheduled at each hospital visits. Hospital visits are scheduled at month 1/2/3/6/12. Questionnaires are scheduled at baseline, month 1, 3, 6, and 12. Follow-up questionnaires will be delivered through Wechat. The primary outcome is ART adherence and CD4+ T cell count.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: APP-based case management service, Behavioral: Standard-of-care followup serviceparticipants in this arm receive the APP-based case management service and standard-of-care followup service. |
| control group | Active comparator | Behavioral: Standard-of-care followup serviceparticipants in the control arm receive standard-of-care followup service |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. diagnosed as HIV positive;
- 2. initiate antiretroviral therapy on the day of recruitment;
- 3. was infected through male same-sex behavior;
- 4. has access to internet on a personal mobile phone;
- 5. has a Wechat account and use it daily;
Key exclusion criteria (2 listed)
- 1. under severe physical or mental condition which precludes study participation;
- 2. being an inpatient of the hospital;
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 |
|---|---|---|
| APP-based case management serviceThe intervention consists of 4 parts, educational articles, online communication with case managers, supportive service information and visit reminder. Educational articles are both delivered automatically and retrieved by participants. Online communication can also be initiated by participants and case managers. Case managers are request to respond to questions from participants as well as care about medication taking behaviors of each patients during the first month. Supportive service information, which include time, location and charges of service providers will be retrieved by participants, with reminders of available service information scheduled at the beginning of every month. Visit reminders are scheduled at one week before due date. | Behavioural | Intervention group |
| Standard-of-care followup serviceWhen participants initiate HIV antiretroviral treatment (ART), they receive 20-minute ART-related education from the case managers, and have physical examination including blood test, CD4 count, hepatic and renal function tests. Subsequent visits are scheduled at month 1, 2, 3, 6 and 12. During each visit, pills enough to cover days until the next visit will be distributed. And patients will be asked about their medication adherence, high risk behavior and side effects experienced. Any relevant questions from patients will be answered. Physical tests are also included in the routine of each visits. | Behavioural | Intervention group, control group |
Primary outcome
self-reported ART medication adherence
Time frame: month 6 after enrolment
Measured by visual analogue scale (VAS) ranging from 0 to 100%. The ART medication visual analogue scale is a instrument for patients to rate their dose taken percentages. 100% of doses taken will be regarded as good adherence.
CD4 count
Time frame: month 6 after enrolment
measured by flow cytometer during visits to hospitals
7 secondary outcomes
Anxiety
Time frame: baseline and month 1/3/6/12 after enrolment
Depression
Time frame: baseline and month 1/3/6/12 after enrolment
Quality of Life
Time frame: baseline and month 3/6/12 after enrolment
ART-related perception
Time frame: baseline and month 1/3/6/12 after enrolment
High risk sexual behavior
Time frame: baseline and month 1/3/6/12 after enrolment
Retention in ART
Time frame: month 1/3/6/12 after enrolment
HIV RNA viral load
Time frame: baseline and month 12 after enrolment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Derived from this study: PubMed 37099367Fan X, Ning K, Liu C, Zhong H, Lau JTF, Hao C, Hao Y, Li J, Li L, Gu J. Uptake of an App-Based Case Management Service for HIV-Positive Men Who Have Sex With Men in China: Process Evaluation Study. J Med Internet Res. 2023 Apr 26;25:e40176. doi: 10.2196/40176.
- Derived from this study: PubMed 31959139Fan X, She R, Liu C, Zhong H, Lau JTF, Hao C, Li J, Hao Y, Li L, Gu J. Evaluation of smartphone APP-based case-management services among antiretroviral treatment-naive HIV-positive men who have sex with men: a randomized controlled trial protocol. BMC Public Health. 2020 Jan 20;20(1):85. doi: 10.1186/s12889-020-8171-5.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available from the principal investigator on reasonable request. Due to the highly sensitive nature of the data collected and the characteristics of this often stigmatized population, no client-level data will be shared until the entire cohort is accrued and completed, even that which is de-identified.
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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.
Jing Gu principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APP-based case management service and Standard-of-care followup service in people with HIV/AIDS, run by Sun Yat-sen University at 1 site in 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 6 inclusion and 2 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 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Linghua Li (+86 13725297174, 870100302@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-reported ART medication adherence (time frame: month 6 after enrolment). 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 NCT03860116, which also lists 2 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 15 Oct 2019.