University of Malaya
Kuala Lumpur, 50603, Malaysia
NCT Number: NCT05271097
This study aims to inform the development of an acceptable and usable smartphone app for transgender women (TGW) in Malaysia to deliver an integrated HIV prevention intervention that incorporates screening and guidance for HIV testing and pre-exposure prophylaxis compared to treatment as usual.
This study is active but is not currently recruiting participants.
18 year and older
Male
Interventional
Not applicable
Kuala Lumpur, 50603, Malaysia
This study aims to inform the development of an acceptable and usable smartphone app for transgender women (TGW) in Malaysia to deliver an integrated HIV prevention intervention that incorporates screening and guidance for HIV testing and pre-exposure prophylaxis (PrEP) compared to treatment as usual.
A new clinic-affiliated app (to be called MyLink2Care) will be developed (by adapting an existing app) and tested to deliver an integrated HIV prevention intervention that incorporates tailored HIV prevention and gender affirming care (GAC) services to TGW in Malaysia. The specific aims of the study include:
Together, these aims will address multilevel barriers to HIV testing and PrEP uptake in Malaysian TGW. Feasibility is high based on the investigators extensive experience with HIV prevention in TGW, theory-guided behavioral interventions, mHealth expertise, and longstanding work in Malaysia.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be shown how to download the app and use the assessment tool.
Participants will be shown how to download the app and use the assessment tool.
Time frame: 6 months
The investigators will use the percentage of individuals screened to determine the feasibility of the MyLink2Care app
Time frame: 6 months
The investigators will use the percentage of individuals eligible to determine the feasibility of the MyLink2Care app
Time frame: 6 months
The investigators will use the percentage of individuals enrolled to determine the feasibility of the MyLink2Care app
Time frame: 6 months
The investigators will use the percentage of individuals retained to determine the feasibility of the MyLink2Care app
Time frame: 6 months
The investigators will determine the percentage of participants that accessed the app, with ≥60% of participants accessing app as lower threshold. The higher the percentage, the higher the feasibility.
Time frame: 6 months
Acceptability will be based on descriptive statistics from the subjective usability measure, with a target mean score of ≥ 50. The higher the score, the higher the acceptability. Minimum score for the scale is 0, highest is 100.
Time frame: 6 months
Acceptability will be based on analysis of qualitative data which includes specific areas of perceived usefulness of the app.
Time frame: 6 months
Acceptability will be based on analysis of qualitative data which includes barriers and facilitators
Time frame: 6 months
Acceptability will be based on analysis of qualitative data which includes usability concerns.
Time frame: 6 months
Acceptability will be based on analysis of qualitative data which includes refinement needed to maximize future implementation.
Time frame: 3 months
The investigators will measure PrEP adherence DBS at 3 months. DBS will quantify tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) in red blood cells (RBC).
Time frame: 6 months
The investigators will measure PrEP adherence DBS at 6 months. DBS will quantify tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) in RBC
Time frame: 3 months
The investigators will measure PrEP adherence using the visual analogue scale at 3 months
Time frame: 6 months
The investigators will measure PrEP adherence using the visual analogue scale at 6 months.
Time frame: 6 months
Preliminary Efficacy of the app will be calculated using the proportion of participants who persist on PrEP. Persistence on PrEP is measured on the app when completing PrEP care.
Yale University
Other
Developing a MHealth HIV Prevention Intervention for Transgender Women (Phase 1 and 2)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05503173
Agnosia, Chronic Pain
Boston, Massachusetts, United States
View Trial DetailsNCT05505942
Behavior, HIV
Boston, Massachusetts, United States
View Trial DetailsNCT00092222
Blood-Borne Infections, Communicable Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT06182241
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
Boston, Massachusetts, United States
View Trial Details