Identifying and Addressing Barriers to Retention in the Cervical Cancer Treatment Cascade Among Women with HIV in South Africa: Part 2

Last updated: February 3, 2025
Sponsor: Boston University Charles River Campus
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cervical Cancer

Hiv

Dysfunctional Uterine Bleeding

Treatment

Retention in cervical cancer care intervention

Clinical Study ID

NCT06182241
7356E
  • Ages > 18
  • Female

Study Summary

The investigators will conduct the formative work that is necessary to develop a novel, multi-level intervention (inclusive of patient- and provider-level components), which will increase awareness of and modify the complex, intersecting factors that contribute to cervical cancer development among cisgender women with HIV (WWH). In Aim 1a, the investigators will explore the multi-level barriers and facilitators to follow-up appointment attendance among WWH who have had a recent high-risk abnormal Pap smear in the past six months, via qualitative interviews with WWH who have either attended at least one follow-up visit (n<10) or have not yet attended a follow-up visit (n<10). In Aim 1b, the investigators will explore provider awareness of the HIV-cervical cancer relationship and perspectives on barriers to retention in care via qualitative interviews (n<8). For Aim 2, The study team will leverage the Aim 1 data, develop a patient-level intervention (1-2 sessions) and a provider toolkit, with the goal of increasing retention in care among WWH who are at heightened risk for cervical cancer. The study team will seek feedback on the manual and the toolkit from providers and from a community advisory board. In Aim 3a, the investigators will test the feasibility and acceptability of the intervention in a pilot randomized control trial (RCT) (n<60). The study team will also assess (1) changes in self-efficacy to attend cervical cancer-related healthcare appointments pre-post intervention, (2) the proportion of women who attend a follow-up appointment, and, of those participants, (3) the proportion of women who complete the next phase of treatment. In Aim 3b, the investigators will explore the feasibility of intervention implementation in the clinic and acceptability of the provider-level intervention components in qualitative interviews with providers, clinic staff, the interventionalists, and other key stakeholders (n<10).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Having a cervix

  • Aged 18+

  • Living with HIV

  • Recent high-risk abnormal Pap results within the last month (if needed, we mayincrease the range by up to 6 months to ensure that we meet our targets).

Exclusion

Exclusion Criteria:

  • Younger than 18 years old

  • HIV-negative

  • No cervix/history of hysterectomy

  • Recent normal or low-risk abnormal Pap results

  • Unable to provide informed consent or assent in English or isiZulu and/or have asignificant psychiatric illness (e.g., active psychotic disorder or untreatedbipolar disorder) that could interfere with participation will be excluded.Potential participants will also be asked if they have any health conditions thatmake it difficult for them to travel to the clinic.

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Retention in cervical cancer care intervention
Phase:
Study Start date:
October 31, 2024
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • MatCH Research Unit (MRU), a Division of the Wits Health Consortium, University of Witwatersrand

    Durban, KwaZulu-Natal 4000
    South Africa

    Active - Recruiting

  • Boston University

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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