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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBoston University Charles River Campus

About this trial

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

Qualifiers

Having a cervix

Aged 18+

Living with HIV

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

Disqualifiers

Younger than 18 years old

HIV-negative

No cervix/history of hysterectomy

Recent normal or low-risk abnormal Pap results

Trial design

Treatments tested in this trial

  • Retention in cervical cancer care intervention

Treatment groups

80 Participants
are divided into 2 treatment groups

Locations

3
South Africa
MatCH Research Unit (MRU), a Division of the Wits Health Consortium, University of Witwatersrand4000, DurbanKwaZulu-Natal, South Africa
United States
Boston University02215, BostonMassachusetts, United States
Massachusetts General Hospital02114, BostonMassachusetts, United States

Sponsors and collaborators

Boston University Charles River Campus

Lead sponsor

University of Witwatersrand, South Africa

Collaborator

Massachusetts General Hospital

Collaborator