LifeSkills Mobile for HIV Prevention
(LifeSkills Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 65
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Los Angeles
Disqualifiers: Severe mental illness, Substance intoxication, others
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This trial will test the LifeSkills Mobile app, which helps young transgender women in the U.S. learn ways to prevent HIV. The app uses empowerment theory to provide information and strategies for avoiding HIV, and it was created with community input.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment LifeSkills Mobile for HIV prevention?
Research on mobile health interventions, like PositiveLinks, shows they can help people with HIV stay engaged in care and improve health outcomes, such as viral suppression. These interventions often include features like educational resources and support groups, which are similar to components of LifeSkills Mobile.
12345What makes the LifeSkills Mobile treatment unique for HIV prevention?
LifeSkills Mobile is unique because it focuses on life skills education, which aims to improve knowledge, attitudes, and abilities related to HIV prevention, rather than directly altering sexual behavior or biological outcomes. This approach is delivered through a mobile platform, making it accessible and adaptable to the needs of young people in various settings.
678910Eligibility Criteria
This trial is for young transgender women, ages 16-29 in the U.S., who have had condomless sex or recent sexual activity and are HIV negative. Participants must identify as transgender or along the feminine spectrum, speak English, be able to consent, own a smartphone or computer, and not suffer from severe mental illness.Inclusion Criteria
Willing and able to provide informed consent/assent
I am between 16 and 29 years old.
Self-reported lifetime history of condomless sex or recent history of sex (anal or vaginal in the past 12 months)
+4 more
Exclusion Criteria
Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at time of enrollment
I tested positive for HIV using a home test kit.
Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of the interview (these patients will be referred immediately for treatment, but may join the study when this is resolved)
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Participants complete an online survey and receive an OraQuick In-Home HIV Test kit
1 week
1 visit (virtual)
Treatment
Participants in the LifeSkills Mobile group complete 4 modules with 20 activities over 6 months
6 months
Self-paced online access
Follow-up
Participants are monitored for changes in sexual risk behavior and HIV incidence
12-48 months
Online surveys every 6 months
Participant Groups
The LifeSkills Mobile app is being tested in this study to see if it can reduce HIV incidence among participants. The effectiveness of the app will be evaluated through a randomized controlled trial involving 5,000 eligible individuals.
2Treatment groups
Experimental Treatment
Active Control
Group I: LifeSkills MobileExperimental Treatment1 Intervention
Access to LifeSkills Mobile app. Participants will complete 4 modules with 20 activities across 6 months. Participants can log in at their convenience but will not be able to access the next module until the previous module is completed.
Group II: Standard of CareActive Control1 Intervention
HIV home testing every 6 months, information regarding sexual and other behaviors that potentiate one's risk for HIV infection, receipt of a fact sheet about PrEP and PEP and referrals to the local PrEP clinics, and sexually transmitted infection testing via an on-line location findings app.
LifeSkills Mobile is already approved in United States for the following indications:
🇺🇸 Approved in United States as LifeSkills Mobile for:
- HIV prevention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UCLALos angeles, CA
UCLALos Angeles, CA
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
Children's Hospital Los AngelesCollaborator
Ann & Robert H Lurie Children's Hospital of ChicagoCollaborator
References
PositiveLinks: A Mobile Health Intervention for Retention in HIV Care and Clinical Outcomes with 12-Month Follow-Up. [2019]Mobile health interventions may help People Living with HIV (PLWH) improve engagement in care. We designed and piloted PositiveLinks, a clinic-affiliated mobile intervention for PLWH, and assessed longitudinal impact on retention in care and viral suppression. The program was based at an academic Ryan White Clinic serving a nonurban population in Central Virginia. The PL intervention included a smartphone app that connected participants to clinic staff and provided educational resources, daily queries of stress, mood and medication adherence, weekly quizzes, appointment reminders, and a virtual support group. Outcomes were analyzed using McNemar's tests for HRSA-1, visit constancy, and viral suppression and nonparametric Wilcoxon signed-rank tests for CD4 counts and viral loads. Of 77 participants, 63% were male, 49% black non-Hispanic, and 72% below the federal poverty level. Participants' achievement of a retention in care benchmark (HRSA-1) increased from 51% at baseline to 88% at 6 months (p
Development and evaluation of a booklet to promote ealthy lifestyle in people with HIV. [2021]To develop and evaluate an educational primer to promote healthy lifestyles in people with HIV.
An Implementation Strategy to Expand Mobile Health Use in HIV Care Settings: Rapid Evaluation Study Using the Consolidated Framework for Implementation Research. [2021]Mobile health (mHealth) apps can provide support to people living with a chronic disease by offering resources for communication, self-management, and social support. PositiveLinks (PL) is a clinic-deployed mHealth app designed to improve the health of people with HIV. In a pilot study, PL users experienced considerable improvements in care engagement and viral load suppression. To promote its expansion to other HIV clinics, we developed an implementation strategy consisting of training resources and on-demand program support.
Usability and Feasibility of an Innovative mLearning Approach for Nurses Providing Option B+ Services in Manica and Sofala Provinces, Mozambique. [2020]The scaling of Option B+ services, whereby all pregnant women who test HIV positive are started on lifelong antiretroviral therapy upon diagnosis regardless of CD4 T-cell count, is ongoing in many high HIV burden, low-resource countries. We developed and evaluated a tablet-based mobile learning (mLearning) training approach to build Option B+ competencies in frontline nurses in central Mozambique. Its acceptability and impact on clinical skills were assessed in maternal child health nurses and managers at 20 intervention and 10 control clinics. Results show that skill and knowledge of nurses at intervention clinics improved threefold compared with control clinics (p = .04), nurse managers at intervention clinics demonstrated a 9- to 10-fold improvement, and nurses reported strong acceptance of this approach. "mLearning" is one viable modality to enhance nurses' clinical competencies in areas with limited health workforce and training budgets. This study's findings may guide future scaling and investments in commercially viable mLearning solutions.
Self-management education programs for people living with HIV/AIDS: a systematic review. [2022]The effectiveness of self-management programs to improve physical, psychosocial, health knowledge, and behavioral outcomes for adults living with HIV has not been well established. This article reviews the effectiveness of self-management education programs to improve physical, psychosocial, health knowledge, and behavior outcomes for adults living with HIV/AIDS. A systematic review of English articles using CINAHL, MEDLINE, and PsycINFO were used to identify and retrieve relevant studies. Each database was searched from its earliest record to October 2010. Search terms included HIV/AIDS, self-management, self-care, patient education, and education programs. Only studies that (1) reported on a HIV-specific intervention that aimed to increase participants HIV-related knowledge through a self-management component, (2) included a control group, (3) provided skills training or targeted behavior change, and (4) reported clinical outcomes were included. Independent data extraction by one author using the methods described in the Cochrane Handbook for Systematic Reviews. A second reviewer checked the data extraction. Six protocols were reported in eight publications (n=1178), all contained elements of self-management interventions. Effect size calculations were not conducted due to limitations in the available data. The review found randomized controlled trials (RCT) evidence sufficient to infer that self-management programs for people living with HIV/AIDS result in short-term improvements in physical, psychosocial, and health knowledge and behavioral outcomes. Statistically significant improvements were reported for intervention participants compared to control participants across most outcomes. There is insufficient evidence to provide conclusions regarding the long-term outcomes of HIV-specific self-management interventions.
Effects and effectiveness of life skills education for HIV prevention in young people. [2008]For 20 years, "life skills" education has been advocated as a key component of HIV and AIDS education for young people. But what do terms such as life skills imply, and what evidence is there that a life skills-based approach really works? This article reviews the literature on the effects and effectiveness of life skills-based education for HIV prevention. Evaluated interventions were identified by using three search strategies. The review identified a surprising number of rigorously designed and evaluated interventions from Africa, Latin America, Asia, and the Pacific. Most interventions used life skills training as a component of the overall education strategy. Programs worked best to positively influence knowledge, attitudes, intentions, skills, and abilities. Programs rarely produced consistent effects on sexual behavior. Also, life skills, training had little effect on biological outcomes. The narrow focus on achieving behavioral outcomes may be at the loss of documenting other positive impacts.
Life skills training as HIV/AIDS preventive strategy in secondary schools: evaluation of a large-scale implementation process. [2016]A life skills and HIV/AIDS education programme was implemented in secondary schools as a strategy to combat the spread of HIV/AIDS among school-going young people in South Africa. As part of a joint effort of the Departments of Health and Education, two teachers per school were trained to implement life skills training and HIV/AIDS education in schools as part of the school curriculum. The implementation of the intervention was evaluated in 24 schools in two educational districts in Gauteng province using an action research approach. Data about the implementation were gathered through interviews and focus group discussions with school principals, teachers and learners. A repeated measurement research design was used to assess the impact of the intervention in terms of knowledge, attitudes and reported risk behaviour in a sample of 667 learners representing learners from grades 8 to 12 from different population groups. Results showed that the programme was not implemented as planned in schools due to organisational problems in the schools, lack of commitment of the teachers and the principal, non-trusting relationships between teachers and learners, lack of resources and conflicting goals in the educational system. In an outcome evaluation over the period of a year it was found that learners' knowledge of HIV/AIDS increased and their attitudes were more positive although the changes may not be attributed to the programme alone. In the post-test more learners were sexually active, although preventive behaviour did not increase. The programme as implemented in the area did not succeed in changing high-risk behaviour patterns among school-going young people. From the evaluation of the intervention a few valuable lessons were learned about the content and implementation of HIV/AIDS preventive interventions, which could be useful in the implementation of various other HIV/AIDS preventive interventions in the community.
Reducing HIV Vulnerability Through a Multilevel Life Skills Intervention for Adolescent Men (The iREACH Project): Protocol for a Randomized Controlled Trial. [2023]Few HIV interventions have demonstrated efficacy in reducing HIV risk among adolescent men who have sex with men (AMSM), and fewer still have recognized the unique needs of AMSM based on race/ethnicity or geographical setting. Recognizing that youths' HIV vulnerability is intricately tied to their development and social context, delivering life skills training during adolescence might delay the onset or reduce the consequences of risk factors for HIV acquisition and equip AMSM with the skills to navigate HIV prevention. This protocol describes the development and testing of iREACH, an online multilevel life skills intervention for AMSM.
The impact of life skills education on adolescent sexual risk behaviors in KwaZulu-Natal, South Africa. [2021]To assess the impact of exposure to life skills education by youth in KwaZulu-Natal Province (KZN, South Africa) on knowledge and behaviors associated with the spread of HIV/AIDS.
Appreciative inquiry into lifeskills-based HIV/AIDS education in South African schools. [2015]With a steady rise in the prevalence of HIV and AIDS throughout the world it has become vital for programme implementers at all levels to ensure that all HIV intervention programmes are effectively put into practice. The present research used qualitative and quantitative data to evaluate the lifeskills-based HIV/AIDS education programme being implemented in primary and secondary schools in South Africa, with special reference to KwaZulu-Natal. A qualitative questionnaire gathered information from nine respondents at three levels: Department of Education district officials, educators and learners. Six key themes were consequently identified to guide the evaluation: communication, empowerment, resources, networking, motivation, and evaluation and feedback. A quantitative questionnaire completed by 30 educators revealed an overall positive attitude towards the programme, regardless of the educator's gender, age or level of formal education. The results are discussed with special reference to continuation and improvement of the lifeskills-based HIV/AIDS education programme.