NCT03896776

A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0)

Completed NA Last updated 7 July 2023

What this trial tests

NA trial testing Keep It Up! 3.0 in HIV/AIDS in 2,125 participants. Completed in 31 March 2023.

Timeline

9 October 2019

Primary endpoint
31 March 2023

31 March 2023

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	2,125
Start date	9 October 2019
Primary completion	31 March 2023
Estimated completion	31 March 2023
Sites	1 location across United States

Drugs / interventions tested

• Keep It Up! 3.0

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →
• Gonorrhea — all drugs for Gonorrhea →
• Chlamydia — all drugs for Chlamydia →

Sponsor

Northwestern University

Who can join

Adults 18 to 34, male only, with HIV/AIDS or Gonorrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Keep It Up! 3.0: Study protocol for a type III hybrid implementation-effectiveness cluster-randomized trial.
   Mustanski B, Saber R, Jones JP, Macapagal K, et al · · 2023 · cited 10× · PMID 36842763 · DOI 10.1016/j.cct.2023.107134
2. Barriers and Facilitators to Implementing Keep It Up!, A Digital Health Intervention, in Community-Based Organizations.
   Zamantakis A, Zapata JP, Greenawalt I, Knapp AA, et al · · 2024 · cited 4× · PMID 39387999 · DOI 10.1007/s10461-024-04525-6
3. 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.
   Mustanski B, Benbow N, Macapagal K, Li D, et al · · 2025 · cited 2× · PMID 40826259 · DOI 10.1007/s10461-025-04838-0
4. 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.
   Zamantakis A, Zapata JP, Smith JD, Danielson EC, et al · · 2026 · cited 1× · PMID 41266922 · DOI 10.1007/s10461-025-04963-w
5. A mixed-methods approach to assessing implementers' readiness to adopt digital health interventions (RADHI).
   Li DH, Zamantakis A, Zapata JP, Danielson EC, et al · · 2024 · cited 1× · PMID 39192345 · DOI 10.1186/s43058-024-00628-2