Development of Implementation Toolkits

NCT06739772 | Completed

• 1 other identifier: 1R21TW012728-01A1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to conduct an intervention program aimed at increasing HPV self-sampling among women living with HIV in Ghana.

Conditions

Self Sampling; Communication Model; Implementation Science; HIV

Outcome Measures

Primary Outcomes (1)

• Cervical cancer screening uptake

  The outcome is screening uptake (i.e., the completion and return of a self-sample kit and pap test completion). Measure: The screening completion outcome will be binary (yes/no), and it will be assessed via the patient clinical records by the doctors at 6 weeks post-intervention. The screening completion outcome will be binary (yes/no)

  6 weeks

Secondary Outcomes (2)

• Screening Test Results

  6 weeks

• Treatment follow-up

  6 weeks

Other Outcomes (4)

• Actionable outcome : Implementation experience

  6 weeks after the intervention

• Actionable factor: Operational experience

  6 weeks after the intervention

• Actionable factor: Adoption or level of endorsement

  6 weeks after the intervention

Study Arms (2)

HPV Self sampling

EXPERIMENTAL

Participants in the intervention group will receive HPV self sampling and behavioral intervention

Behavioral: HPV Self-Sampling and Behavior Intervention; Behavioral: Participants in the intervention group will receive HPV self sampling and behavioral intervention

Control Group

NO INTERVENTION

Participants in the control group will receive enhance standard care

Interventions

HPV Self-Sampling and Behavior Intervention BEHAVIORAL

Participants in the intervention group will receive HPV self sampling and behavioral intervention

HPV Self sampling

Participants in the intervention group will receive HPV self sampling and behavioral intervention BEHAVIORAL

Received enhance standard care

HPV Self sampling

Eligibility Criteria

• Age: 25 Years - 65 Years
• Gender Eligibility Details: Identified female at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General eligibility criteria for these stakeholders include (1) the ability to give consent per Institutional Review Board stipulations, (2) residing in the central region of Ghana, (3) having no medical, psychological, or social characteristics that would interfere with the ability to fully participate, and (4) the willingness to participate in this study.

You may not qualify if:

• Women will be excluded if they are pregnant or have had a hysterectomy. WLWH (female-identified at birth) who have a cervix are the main target population to develop the HOPE toolkit.

Sponsors & Collaborators

• Baylor University: lead

Study Sites (1)

University of Cape Coast Teaching Hospital

Cape Coast, Central Region, Ghana

Location

Related Publications (2)

• Asare M, Ebu Enyan NI, Sencherey VL, Lamptey-Mills E, Ken-Amoah S, Akakpo PK, Sturdivant RX, Obiri-Yeboah D. Culturally adapting and evaluating an evidence-based communication intervention with HPV self-sampling to improve cervical cancer screening among women living with HIV in Ghana: a mixed-methods study. BMJ Open. 2025 Dec 31;15(12):e105852. doi: 10.1136/bmjopen-2025-105852.

  PMID: 41475829 DERIVED

• Asare M, Obiri-Yeboah D, Ken-Amoah S, Akakpo PK, Enyan NIE, Asmah E, Sturdivant RX. HPV self-sampling for cervical cancer screening among women living with HIV in Ghana: protocol for a hybrid type 1 effectiveness-implementation randomized controlled trial. Trials. 2025 Nov 26;26(1):550. doi: 10.1186/s13063-025-09262-2.

  PMID: 41299750 DERIVED

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Matthew Asare, PhD

  Baylor University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 18, 2024
• Study Start: February 10, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

GH (1)