NCT06566417

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 22, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2025

Completed
Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

1.3 years

First QC Date

July 30, 2024

Last Update Submit

November 8, 2025

Conditions

Keywords

HIV preventionHIV Pre-exposure prophylaxisSentiment analysis

Outcome Measures

Primary Outcomes (2)

  • 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. From these analyses, the investigators will generate multiple measure datasets to compare with the VOICE risk score (i.e., a combined assessment of HIV risk based on age, marital status, sexual partner support, sexual partner sexual behavior, and alcohol use), as assessed in the study participants at the time of SMS/social media data collection.

    6 months

  • 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 (i.e., a combined assessment of HIV risk based on age, marital status, age at sexual debut, number of sexual partners, use of injectable contraception, and history of sexually transmitted infections), as assessed in the study participants at the time of SMS/social media data collection.

    One day

Secondary Outcomes (1)

  • Association of artificial intelligence measure datasets with HIV test results

    One day

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Inability to provide informed consent (e.g., intoxication, developmental delay)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KEMRI

Kisumu, Kenya

Location

Study Officials

  • Jessica Haberer, MD, MS

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Director of Research

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 22, 2024

Study Start

February 1, 2024

Primary Completion

May 15, 2025

Study Completion

July 20, 2025

Last Updated

November 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
We will make this data available after publishing our findings.
Access Criteria
We will post a de-identified dataset to the Harvard Dataverse, a datasharing platform.

Locations