NCT06182241

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

StatusCompleted

PhaseNot applicable

SponsorBoston University Charles River Campus

Primary completionSep 30, 2026

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Record History

All 9 versions: 9 with changes below. See every version on ClinicalTrials.gov ↗

Minor Oct 23, 2026 Trial completed Show 4 more changesShow less
- Final enrollment: 62 participants (planned 80)
- Eligibility criteria expanded, about 17 words
- Secondary endpoints: details revised at 1 of 2 entries
- Collaborators: 2 to 3
Minor Jul 24, 2026 Trial status changed: Recruiting → Active, Not Recruiting
- Primary and study completion pushed from Jun 30, 2026 to Sep 30, 2026
- Secondary endpoints: details revised at 1 of 2 entries
v8
Minor Jul 22, 2026 Trial status: Recruiting to Active, Not Recruitingv7 Show 4 more changesShow less
- Primary and study completion dates: Jun 30, 2026 to Sep 30, 2026
- Eligibility criteria expanded, about 91 words
- Secondary endpoints: details revised at 2 of 2 entries
- Site details revised at 3 of 3 sites
Notable Jun 23, 2026 Trial status: Not Yet Recruiting to Recruiting
- Primary and study completion dates: May 31, 2026 to Jun 30, 2026
- Start date changed from estimate of Oct 15, 2025 to Nov 17, 2025
- Site details revised at 3 of 3 sites
v6
Notable Sep 15, 2025 Start date: Oct 31, 2024 to Oct 15, 2025v5 Show 4 more changesShow less
- Trial status: Recruiting to Not Yet Recruiting
- Primary and study completion dates: Feb 28, 2026 to May 31, 2026
- Secondary endpoints: details revised at 1 of 2 entries
- Site details revised at 3 of 3 sites

Show 3 earlier versionsHide 3 earlier versions

Notable Feb 3, 2025 Trial status: Not Yet Recruiting to Recruiting
- Start date changed from estimate of Sep 1, 2024 to Oct 31, 2024
- Site details revised at 3 of 3 sites
v4
Notable Aug 5, 2024 Start date: Mar 1, 2024 to Sep 1, 2024v3
Notable Jan 31, 2024 Enrollment target: 40 to 80v2 Show 7 more changesShow less
- Primary and study completion dates: Feb 28, 2025 to Feb 28, 2026
- Primary endpoints: 3 to 2
- Study sites: 2 to 3
- Secondary endpoints: 3 to 2
- Collaborators: 1 to 2
- Study arms: 1 to 2
- Study title expanded, about 2 words

Dec 13, 2023 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Feasibility of the intervention

Timeframe: About 1 month after the start of intervention and at about 3 months after the start of the intervention

Acceptability of the intervention

Timeframe: About 1 month after the start of intervention and at about 3 months after the start of the intervention

Secondary (2)

Self-efficacy to attend cervical cancer-related health care appointment

Follow-up appointment attendance

Arms and interventions

Participant interventionExperimental

The intervention group will consist of two sessions, conducted in-person, coupled with text-based client navigation.The intervention group will complete three major assessments: baseline (T1), at the conclusion of the intervention (T2), and a three-month follow-up (T3). Until the follow-up assessment, the interventionist will send participants 2-3 SMS messages (one-way) per month. The content of these messages will be developed collaboratively between the participant and the interventionist during each session; messages could include reminders about follow-ups and/or prompts to use new skills and resources for navigating specific barriers.

Enhanced treatment as usualNo intervention

The enhanced treatment as usual (ETAU) group will receive treatment as usual, including being notified of their Pap results and instructed to set up a follow-up appointment if needed, as is typical in routine care. They will additionally receive an information sheet describing Pap smears and the relationship between HIV, HPV, and cervical cancer. The ETAU group will complete the T1, T2, and T3 assessments.

Behavioral: Retention in cervical cancer care intervention

Sites

3 sites in 2 countries

United States 2, South Africa 1

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 (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).

Trial details

Enrollment: 62 participants (actual)
Started: Nov 17, 2025
Study completion: Sep 30, 2026
Eligibility: 18 and older, female only, no healthy volunteers
Design: Interventional, randomized, open label, treatment
Oversight: No data monitoring committee
Conditions: Acquired Immunodeficiency Syndrome, Uterine Cervical Neoplasms, Cervical Cancer, Hiv
Collaborators: University of Witwatersrand, South Africa, Massachusetts General Hospital, National Cancer Institute (NCI)
First posted: Dec 26, 2023
Registry updated: Oct 27, 2026
Last verified: Oct 2026

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