NCT03896776

Brief Summary

This study evaluates and compares two implementation strategies of an online HIV prevention intervention: Strategy 1 in which community-based organizations apply, and are selected, for funding to deliver Keep It Up! through current HIV testing programs; and Strategy 2 which is a "direct-to-consumer" model where centralized staff at Northwestern University recruit participants nationally through online advertising campaigns and manage engagement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,125

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

March 28, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

October 9, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

3.5 years

First QC Date

March 28, 2019

Last Update Submit

July 6, 2023

Conditions

HIV/AIDSGonorrheaChlamydia

Outcome Measures

Primary Outcomes (1)

  • Public Health Impact (reach X effectiveness)

    Public Health Impact (PHI) involves the reach into the county's YMSM community, weighted by HIV risk (i.e., engagement of YMSM from higher risk communities is valued more), and effectiveness at reducing HIV risk, defined as condomless anal sex, STIs, and adherent PrEP use (i.e., three major risk factors for HIV expected to be modified by KIU!).

    12 Weeks

Study Arms (2)

Community Based Organization (CBO) Delivery

EXPERIMENTAL

CBOs will be selected through a Request for Proposal (RFP) process. The RFP will describe research and KIU! delivery activities to be conducted as part of the study and allowable budget to carry out the activities. The RFP will ask CBOs to describe past experience providing HIV services for YMSM. Selected CBOs will recruit participants into the intervention and encourage participants to complete each session of intervention content at baseline, 6 Week Follow-up, and 12 Week Follow-up. Participants in the CBO delivery arm will receive baseline HIV and STI testing at a CBO. Participants will receive an at-home STI test kit at 12 Week Follow-up if testing is not provided at their CBO site.

Behavioral: Keep It Up! 3.0

Direct to Consumer (DTC) Delivery

EXPERIMENTAL

In the DTC arm, participants will be recruited online via paid social media advertising (e.g., Facebook, Instagram). Advertisements will target placements by age, gender, sexual orientation, racial background, "likes" that are relevant to YMSM (e.g., local LGBT organizations, "out" celebrities), and location (i.e., target county). Dating/sex-seeking apps (e.g., Grindr) will also be used to recruit YMSM, using a similar advertising approach as social media. These online recruitment strategies will be supplemented by referrals from local organizations and participant registries, and snowball recruitment. Study staff at Northwestern University will manage this recruitment process and encourage participants to complete each session of intervention content at baseline, 6 Week Follow-up, and 12 Week Follow-up. Participants in the DTC delivery arm will receive at-home HIV and STI test kits at baseline. Participants will receive an at-home STI test kit at 12 Week Follow-up.

Behavioral: Keep It Up! 3.0

Interventions

Keep It Up! 3.0BEHAVIORAL

KIU! is an online HIV prevention intervention developed for high-risk young men who have sex with men (YMSM) who recently tested HIV negative. Content was developed in collaboration with YMSM-serving CBOs and subjected to usability testing with diverse YMSM. The Information-Motivation-Behavioral Skills model and eLearning principles guided development of highly interactive, engaging, and culturally relevant health messages. KIU! involves 7 modules completed across 3 sessions, totaling \~1 hour of main content, plus 2 booster sessions at 6- and 12-week follow-ups. Each module is based on a setting or situation relevant to YMSM (e.g., connecting to the gay community and meeting guys through apps), with developmentally appropriate behavior change content embedded. KIU! uses diverse delivery methods (e.g. videos, animation, games) to address HIV knowledge gaps, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors.

Also known as: KIU! 3.0
Community Based Organization (CBO) DeliveryDirect to Consumer (DTC) Delivery

Eligibility Criteria

Age18 Years - 34 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsCisgender men or non-binary
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • recently received an HIV negative test result OR self-report negative or unknown HIV status
  • speaks/reads English
  • has an active email address

You may not qualify if:

  • has not been on PrEP and adherent for 6 months prior

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (4)

  • Zamantakis A, Zapata JP, Smith JD, Danielson EC, Macapagal K, Saber R, Li D, Benbow N, Mustanski B. Incentivizing Prevention: Community Based Organizations' Perceptions on Financial Incentives for Recruitment and Retention of Participants in Keep it Up! (KIU!), an eHealth HIV Prevention Intervention. AIDS Behav. 2025 Nov 21. doi: 10.1007/s10461-025-04963-w. Online ahead of print.

    PMID: 41266922DERIVED

  • Mustanski B, Benbow N, Macapagal K, Li D, Madkins K, Saber R, Linas B, Smith JD, Brown CH, Munroe S, Reddy S, Schackman BR, Swann G, Janulis P, Zamantakis A, Zapata JP. Comparing Implementation and Effectiveness Outcomes for Two Implementation Strategies of the Keep It Up! Digital HIV Prevention Program: A Type 3 Hybrid Effectiveness-Implementation Trial. AIDS Behav. 2025 Dec;29(12):4030-4042. doi: 10.1007/s10461-025-04838-0. Epub 2025 Aug 19.

    PMID: 40826259DERIVED

  • Zamantakis A, Zapata JP, Greenawalt I, Knapp AA, Benbow N, Mustanski B. Barriers and Facilitators to Implementing Keep It Up!, A Digital Health Intervention, in Community-Based Organizations. AIDS Behav. 2024 Dec;28(12):3944-3955. doi: 10.1007/s10461-024-04525-6. Epub 2024 Oct 10.

    PMID: 39387999DERIVED

  • Li DH, Zamantakis A, Zapata JP, Danielson EC, Saber R, Benbow N, Smith JD, Swann G, Macapagal K, Mustanski B. A mixed-methods approach to assessing implementers' readiness to adopt digital health interventions (RADHI). Implement Sci Commun. 2024 Aug 27;5(1):91. doi: 10.1186/s43058-024-00628-2.

    PMID: 39192345DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeGonorrheaChlamydia Infections

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesNeisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSexually Transmitted Diseases, BacterialChlamydiaceae Infections

Study Officials

  • Brian Mustanski, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Institute for Sexual and Gender Minority Health and Wellbeing

Study Record Dates

First Submitted

March 28, 2019

First Posted

April 1, 2019

Study Start

October 9, 2019

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

July 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

The PI agrees to develop a de-identified database, codebook, and mechanism by which IPD could be shared with other investigators upon approval of the PI. Data will be available for request approximately 6 months after completion of the project. Interested investigators will be asked to complete a standardized request form stating the specific aims of the analysis, the analytic plans, resources the requestors have to carry out the project, the proposed timeline, and distribution goals (manuscripts and/or grant application). The PI will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to undertake the request, how data will be protected/managed, and whether there are sufficient resources to honor the request. If any of these issues are problematic, the PI will attempt to negotiate a fair resolution with the interested parties and/or with NIH program staff.

Locations

US(1)