Chatbot for HIV Prevention

Recruiting at 3 trial locations

Overseen By Zhao Ni

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Antiretrovirals

Disqualifiers: Non-resident US South, others

Compensation: Varies

Number of Visits: 30

145 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to develop a chatbot intervention to promote PrEP awareness and uptake among Black men who have sex with men (MSM) in the Southern United States.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have received antiretroviral therapy (ART) treatment.

What data supports the effectiveness of the treatment Chatbot for PrEP Awareness?

Research suggests that digital tools like conversational agents can help increase the uptake of PrEP by addressing barriers faced by high-risk groups. Additionally, mobile health interventions have shown promise in improving adherence to PrEP, which is crucial for its effectiveness in preventing HIV. ^{1 2 3 4 5}

Is the Chatbot for HIV Prevention safe for humans?

The research on the gamified mobile health intervention for PrEP adherence, called mSMART, showed no significant functional difficulties or study dropouts, indicating it was generally safe and well-received by participants. ^{1 2 6 7 8}

How is the Chatbot for PrEP Awareness treatment different from other HIV prevention treatments?

The Chatbot for PrEP Awareness is unique because it uses artificial intelligence to provide information and support for HIV prevention, making it more accessible and engaging, especially for hard-to-reach populations. Unlike traditional methods, this chatbot can guide users through the process of accessing PrEP, answer questions, and facilitate appointments and medication delivery, all through a virtual platform. ^{4 9 10 11 12}

Research Team

Zhao Ni

Principal Investigator

Yale University

Eligibility Criteria

This trial is for cisgender Black men who have sex with men (MSM), are at least 18 years old, speak English, and have had condomless sex in the past 6 months. They must be HIV negative or untested and have Internet access.

Inclusion Criteria

Speaking English

Having Internet access

HIV negative or untested

Exclusion Criteria

Having lived in the US South less than 3 months

I have been treated with antiretroviral therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage with a chatbot intervention to promote PrEP awareness and uptake

12 weeks

Baseline, 30 days, 60 days, and 90 days assessments

Follow-up

Participants are monitored for changes in PrEP awareness and uptake, usability, and other secondary outcomes

4 weeks

Treatment Details

Interventions

• Chatbot for PrEP Awareness

Trial Overview The study is testing a chatbot designed to increase awareness and use of PrEP (a medication to prevent HIV) among Black MSM in the Southern US compared to general educational messages about PrEP.

Participant Groups

Group I: Intervention group Experimental Treatment 1 Intervention

Group II: Control group Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Findings from Research

The mSMART mobile health intervention showed high feasibility and acceptability among 15 Black men who have sex with men (MSM) already prescribed PrEP, with an impressive 82% daily usage rate and positive feedback on user-friendliness.

Participants demonstrated improved PrEP adherence, as indicated by biomarker scores, suggesting that gamified interventions like mSMART could effectively enhance medication adherence and reduce barriers to taking PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Efficacy of a Gamified Mobile Health Contingency Management Intervention for PrEP Adherence Among Black MSM. Mitchell, JT., Burns, CM., Atkinson, B., et al.[2023]

In a randomized clinical trial involving 229 MSM participants, providing automated feedback through a mobile app did not reduce the number of participants with poor adherence to preexposure prophylaxis (PrEP), with 16% in the intervention group showing poor adherence compared to 11% in the control group.

However, the app feedback significantly increased the proportion of participants achieving excellent adherence (48% in the intervention group vs. 31% in the control group), indicating that while it didn't help those struggling with adherence, it did support those already adhering well to PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving adherence to daily preexposure prophylaxis among MSM in Amsterdam by providing feedback via a mobile application. van den Elshout, MAM., Hoornenborg, E., Achterbergh, RCA., et al.[2023]

Nearly half of the participants (47%) who started pre-exposure prophylaxis (PrEP) for HIV prevention discontinued its use, primarily due to systemic issues such as financial problems and logistical barriers related to clinics and pharmacies.

Behavioral factors and concerns about medication side effects also contributed to discontinuation, highlighting the need for addressing both systemic and personal factors to improve PrEP retention and engagement in care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reasons for PrEP Discontinuation After Navigation at Sexual Health Clinics: Interactions Among Systemic Barriers, Behavioral Relevance, and Medication Concerns. Unger, ZD., Golub, SA., Borges, C., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Efficacy of a Gamified Mobile Health Contingency Management Intervention for PrEP Adherence Among Black MSM. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Get2PrEP: An Electronic Medical Record Laboratory Comment Increased Safe Sex Counseling But Not Preexposure Prophylaxis Services at a Large Urban Academic Medical Center in Northern Manhattan. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Potential Role of Conversational Agents in Encouraging PrEP Uptake. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Texting Lost-to-follow-up PrEP Patients from a San Francisco Sexual Health Clinic. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Improving adherence to daily preexposure prophylaxis among MSM in Amsterdam by providing feedback via a mobile application. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Acceptability of drug detection monitoring among participants in an open-label pre-exposure prophylaxis study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Influence of Participant Perceptions of Adherence-Related Interactions with Study/Study Team on Drug Levels: HPTN069 Analysis of Self-Reported Adherence Experiences While on Study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Reasons for PrEP Discontinuation After Navigation at Sexual Health Clinics: Interactions Among Systemic Barriers, Behavioral Relevance, and Medication Concerns. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

Increasing Participation in a TelePrEP Program for Sexual and Gender Minority Adolescents and Young Adults in Louisiana: Protocol for an SMS Text Messaging-Based Chatbot. [2023]

10. Canada pubmed.ncbi.nlm.nih.gov

Formative Evaluation of the Acceptance of HIV Prevention Artificial Intelligence Chatbots By Men Who Have Sex With Men in Malaysia: Focus Group Study. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Chatbots for HIV Prevention and Care: a Narrative Review. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Developing and Testing a Chatbot to Integrate HIV Education Into Family Planning Clinic Waiting Areas in Lusaka, Zambia. [2022]