NCT06182241Completed
Identifying and Addressing Barriers to Retention in the Cervical Cancer Treatment Cascade Among Women With HIV in South Africa: Part 2
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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 (2 sessions) and a provider toolkit, with the goal of increasing retention in care among WWH who are at heightened risk for cervical cancer. 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 at baseline, end of intervention, and three-months post-baseline, (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 and clinic staff (n\<10).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 30 Nov 2023
- Start date
- 17 Nov 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Boston University Charles River Campus
- Diseases
- HIV, Cervical cancer
- NCT number
- NCT06182241
What you commit to
- Study type: Interventional
- Participants enrolled: 62
- From 17 Nov 2025 to the primary completion date, 30 Sept 2026
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- HIV-negative
- No cervix/history of hysterectomy
- Unable to provide informed consent or assent in English or isiZulu and/or have a significant psychiatric illness (e.g., active psychotic disorder or untreated bipolar disorder) that could interfere with participation will be excluded. Potential participants will also be asked if they have any health conditions that make it difficult for them to travel to the clinic.
- Aim 3 criteria:
- HIV-negative
- No cervix/history of hysterectomy
- Unable to provide informed consent in English or isiZulu and/or have a significant psychiatric illness (e.g., active psychotic disorder or untreated bipolar disorder) that could interfere with participation will be excluded. Potential participants will also be asked if they have any health conditions that make it difficult for them to travel to the clinic.
Age
- Younger than 18 years old
- Younger than 18 years old
Other
- Recent normal or low-risk abnormal Pap results
Who the study is looking for
- 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).
- Having a cervix
- Aged 18+
- Living with HIV
- Recent Pap smear test (within the past two months).
Criteria the registry did not label
- Aim 1 criteria:
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boston University Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| MatCH Research Unit (MRU), a Division of the Wits Health Consortium, University of Witwatersrand Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.