HIV PreventionSMaaRTNCT06566417
Social Media as a Risk Tool for HIV Prevention Needs
An observational study of HIV Prevention and HIV Preexposure Prophylaxis, run by Massachusetts General Hospital at 1 site in Kenya.
Trial summary
The impact of effective HIV prevention tools is limited because many people do not know that they are at risk for HIV acquisition, despite the availability of various risk assessment scores and criteria. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, HIV Preexposure Prophylaxis
- How many people
- 400 participants
- Where
- 1 siteKenya
- Study dates
- 1 Feb 2024to 20 Jul 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Research assistants will recruit young Kenyan women (ages 18-24), attending one of four clinics for any health services. Smart phone ownership and use of SMS, WhatsApp, or other social media is required.
Who may be able to join
- Identifying as a young woman (age 18-24 years)
- Attending clinic for any health services, including PrEP and HIV testing
- Smart phone ownership
- Ability to understand Kiswahili, DhoLuo, and/or English
- Use of SMS, WhatsApp, and/or other types of social media
Who cannot join
- Inability to provide informed consent (e.g., intoxication, developmental delay)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Sentiment Analysis and Social Media to Understand HIV Prevention Needs Among Young Women in Kenya
The impact of effective HIV prevention tools is limited because many people do not know that they are at risk for HIV acquisition, despite the availability of various risk assessment scores and criteria. This proposal aims to use a novel data science approach to assessing HIV prevention needs among 400 young women in Kisumu, Kenya- namely, topic modeling and network analysis of text and/or social media messages (e.g., WhatsApp, Instagram, Twitter). The study will involve in-depth assessment of relevant ethical and logistical factors to ensure appropriate and optimized use of a sentiment analysis tool for implementation in routine clinical care.
Read the detailed description
In the Social Media as a Risk Tool (SMaaRT) Study, the investigators hypothesize that topic modeling of SMS/social media data combined with network analysis among young women in Kenya will correlate well with existing HIV risk scales and ultimately yield a better understanding of HIV prevention needs. The investigators propose the following aims:
- Explore ethical factors that may influence analysis of SMS and social media messages. Research assistants will conduct individual qualitative interviews with up to 32 young women (16 who would and 16 who would not provide SMS/social media data, stratified among four clinic sites) and one focus group of five Kenyan bioethicists. Questions will explore ethical concerns from individual and bystander (e.g., contacts involved in SMS/social media) perspectives and differences in ethical issues by type of social media (e.g., conversations vs posts). Follow-up interviews will be conducted with the women who provide SMS and/or social media data (in Aim 2).
- Conduct topic modeling and network analysis of SMS and social media messages to predict HIV prevention needs among young women in Kenya. Working with four clinical sites in Kisumu, study staff will ask approximately 400 women (ages 18-24) seeking HIV testing, PrEP, and other health services to download six months of SMS/social media messages (e.g., WhatsApp, Instagram, Twitter) as a one-time procedure. For those providing data, research assistants will assess social networks engaged via SMS/social media (e.g., anonymously labeled as peers, sexual partners), administer multiple HIV risk assessments (e.g., VOICE, Wand risk scores), and obtain HIV test results. Data analysts will use automated structural topic modelling to determine "topics" (word clusters) and assess for association with other risk assessments (primary outcome) and HIV test results (exploratory outcome), and will also evaluate the impact of social networks, SMS/social media type, data volume, and language type on outcomes. Data collection and analysis will conform to Aim 1 findings.
- Assess practical factors that may influence use of a sentiment analysis tool in routine care. In a needs assessment based on Implementation Mapping, research assistants will conduct four focus groups with five staff per clinic and two focus groups with five young women each to explore staffing best suited to implement a sentiment analysis tool and how it could be best integrated into routine care. The investigators will also assess available resources to determine optimal efficiency in developing a preliminary implementation strategy.
- Conditions
- HIV Prevention, HIV Preexposure Prophylaxis
- Keywords
- HIV prevention, HIV Pre-exposure prophylaxis, Sentiment analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of Artificial Intelligence Measure Datasets With the Wand Risk Score
The investigators will compare the above-noted measure datasets with the Wand risk score as assessed in the study participants at the time of SMS/social media data collection.
The Wand risk score is an empirically validated HIV prediction tool designed to estimate the probability of HIV acquisition in women. It calculates a total score (max 50 pts): age <20 years (11 pts), 20-24 years (10 pts), 25-29 years (6 pts), 30+ years (0 pts); marital status of single/not cohabitating (13 pts), married/cohabitating (0 pts); # sexual partners in last 3 months of 3 or more (5 pts), <3 (0 pts); age at sexual debut of <16 years (3 pts), 16+ years (0 pts); parity (# of births) of 0-1 births (10 pts), 2 births (8 pts), 3+ births (0 pts); ever diagnosed with an STI as yes (4 pts), no (0 pts); and use of injectable contraception as yes (4 pts), no (0 pts). A higher score denotes a higher HIV risk. The total possible range is 0-50.
Measured: 6 months of data given at one time
Association of Artificial Intelligence Measure Datasets With the VOICE Risk Score
Analysts will examine 6 months of SMS/social media message content from each of the 400 study participants using three computational linguistic methods: 1) sentiment, valence, and arousal analysis; 2) topic modeling; 3) simple textual counts. Analysts will also perform network analysis with up to 20 contacts from each participant to understand how often and with which parties the participant communicates most frequently. These networks will be examined temporally to see if any of the connections have grown or weakened over time.
The VOICE risk score (modified to not use biological markers) is a measure of behavioral and demographic factors to determine HIV risk: <25 y/o (2 pts), unmarried or not living with a partner (2 pts), primary partner has other partners (2 pts), partner does not provide financial support (1 pt), alcohol use in the last 3 months (1 pt). A higher score denotes a greater HIV risk. The total possible range is 0-8.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start1 Feb 2024
- Primary completion15 May 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, KEMRI-Wellcome Trust Collaborative Research Program, North Carolina State University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jessica Haberer, MD, Massachusetts General Hospital
- Investigators
- Jessica Haberer, MD, MS, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566417
- Sponsor's protocol ID
- 2023P001625
- Other IDs
- 1R21MH132436-01A1
- Acronym
- SMaaRT
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2024
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This project will release and share final de-identified research data and materials from NIH-supported research for use by other researchers in a timely manner. Due to the sensitive nature of the SMS/social media messages, that data will be deleted at the conclusion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Sentiment Analysis and Social Media to Understand HIV Prevention Needs Among Young Women in Kenya
- ClinicalTrials.gov ID
- NCT06566417
- Acronym / sponsor ID
- SMaaRT / 2023P001625
- Conditions
- HIV Prevention, HIV Preexposure Prophylaxis
- Keywords
- HIV prevention, HIV Pre-exposure prophylaxis, Sentiment analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, KEMRI-Wellcome Trust Collaborative Research Program, North Carolina State University, National Institute of Mental Health (NIMH)
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 22 Aug 2024 (actual)
- Results
- Posted 31 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The impact of effective HIV prevention tools is limited because many people do not know that they are at risk for HIV acquisition, despite the availability of various risk assessment scores and criteria. This proposal aims to use a novel data science approach to assessing HIV prevention needs among 400 young women in Kisumu, Kenya- namely, topic modeling and network analysis of text and/or social media messages (e.g., WhatsApp, Instagram, Twitter). The study will involve in-depth assessment of relevant ethical and logistical factors to ensure appropriate and optimized use of a sentiment analysis tool for implementation in routine clinical care.
Detailed description
In the Social Media as a Risk Tool (SMaaRT) Study, the investigators hypothesize that topic modeling of SMS/social media data combined with network analysis among young women in Kenya will correlate well with existing HIV risk scales and ultimately yield a better understanding of HIV prevention needs. The investigators propose the following aims:
- Explore ethical factors that may influence analysis of SMS and social media messages. Research assistants will conduct individual qualitative interviews with up to 32 young women (16 who would and 16 who would not provide SMS/social media data, stratified among four clinic sites) and one focus group of five Kenyan bioethicists. Questions will explore ethical concerns from individual and bystander (e.g., contacts involved in SMS/social media) perspectives and differences in ethical issues by type of social media (e.g., conversations vs posts). Follow-up interviews will be conducted with the women who provide SMS and/or social media data (in Aim 2).
- Conduct topic modeling and network analysis of SMS and social media messages to predict HIV prevention needs among young women in Kenya. Working with four clinical sites in Kisumu, study staff will ask approximately 400 women (ages 18-24) seeking HIV testing, PrEP, and other health services to download six months of SMS/social media messages (e.g., WhatsApp, Instagram, Twitter) as a one-time procedure. For those providing data, research assistants will assess social networks engaged via SMS/social media (e.g., anonymously labeled as peers, sexual partners), administer multiple HIV risk assessments (e.g., VOICE, Wand risk scores), and obtain HIV test results. Data analysts will use automated structural topic modelling to determine "topics" (word clusters) and assess for association with other risk assessments (primary outcome) and HIV test results (exploratory outcome), and will also evaluate the impact of social networks, SMS/social media type, data volume, and language type on outcomes. Data collection and analysis will conform to Aim 1 findings.
- Assess practical factors that may influence use of a sentiment analysis tool in routine care. In a needs assessment based on Implementation Mapping, research assistants will conduct four focus groups with five staff per clinic and two focus groups with five young women each to explore staffing best suited to implement a sentiment analysis tool and how it could be best integrated into routine care. The investigators will also assess available resources to determine optimal efficiency in developing a preliminary implementation strategy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Research assistants will recruit young Kenyan women (ages 18-24), attending one of four clinics for any health services. Smart phone ownership and use of SMS, WhatsApp, or other social media is required.
Key inclusion criteria (5 listed)
- Identifying as a young woman (age 18-24 years)
- Attending clinic for any health services, including PrEP and HIV testing
- Smart phone ownership
- Ability to understand Kiswahili, DhoLuo, and/or English
- Use of SMS, WhatsApp, and/or other types of social media
Key exclusion criteria (1 listed)
- Inability to provide informed consent (e.g., intoxication, developmental delay)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association of Artificial Intelligence Measure Datasets With the Wand Risk Score
Time frame: 6 months of data given at one time
The investigators will compare the above-noted measure datasets with the Wand risk score as assessed in the study participants at the time of SMS/social media data collection. The Wand risk score is an empirically validated HIV prediction tool designed to estimate the probability of HIV acquisition in women. It calculates a total score (max 50 pts): age <20 years (11 pts), 20-24 years (10 pts), 25-29 years (6 pts), 30+ years (0 pts); marital status of single/not cohabitating (13 pts), married/cohabitating (0 pts); # sexual partners in last 3 months of 3 or more (5 pts), <3 (0 pts); age at sexual debut of <16 years (3 pts), 16+ years (0 pts); parity (# of births) of 0-1 births (10 pts), 2 births (8 pts), 3+ births (0 pts); ever diagnosed with an STI as yes (4 pts), no (0 pts); and use of injectable contraception as yes (4 pts), no (0 pts). A higher score denotes a higher HIV risk. The total possible range is 0-50.
Association of Artificial Intelligence Measure Datasets With the VOICE Risk Score
Time frame: 6 months
Analysts will examine 6 months of SMS/social media message content from each of the 400 study participants using three computational linguistic methods: 1) sentiment, valence, and arousal analysis; 2) topic modeling; 3) simple textual counts. Analysts will also perform network analysis with up to 20 contacts from each participant to understand how often and with which parties the participant communicates most frequently. These networks will be examined temporally to see if any of the connections have grown or weakened over time. The VOICE risk score (modified to not use biological markers) is a measure of behavioral and demographic factors to determine HIV risk: <25 y/o (2 pts), unmarried or not living with a partner (2 pts), primary partner has other partners (2 pts), partner does not provide financial support (1 pt), alcohol use in the last 3 months (1 pt). A higher score denotes a greater HIV risk. The total possible range is 0-8.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. This project will release and share final de-identified research data and materials from NIH-supported research for use by other researchers in a timely manner. Due to the sensitive nature of the SMS/social media messages, that data will be deleted at the conclusion of the study.
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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.
Jessica Haberer, MD, MS principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Prevention and HIV Preexposure Prophylaxis, run by Massachusetts General Hospital at 1 site in Kenya.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 31 Aug 2026. 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 Kenya. 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?
Yes. Results are posted in the registry (first posted 31 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of Artificial Intelligence Measure Datasets With the Wand Risk Score (time frame: 6 months of data given at one time). 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?
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 31 Aug 2026.