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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Cervical Cancer; Hiv
• Intervention / Treatment: Behavioral: Retention in cervical cancer care intervention

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4000
      • MatCH Research Unit (MRU), a Division of the Wits Health Consortium, University of Witwatersrand
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Boston University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Aim 1 criteria:

Inclusion Criteria:

• 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).

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 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:

Inclusion Criteria:

• Having a cervix
• Aged 18+
• Living with HIV
• Recent Pap smear test (within the past two months).

Exclusion Criteria:

• Younger than 18 years old
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participant intervention; 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.	Behavioral: Retention in cervical cancer care intervention; The participant intervention will be two sessions, conducted in-person, coupled with text-based client navigation with women who received a recent Pap smear test. The intervention integrates (1) information to improve awareness of cervical cancer susceptibility and treatment, (2) brief cognitive behavioral therapy (CBT) skills to reduce individual-level barriers, (3) problem-solving to increase social support, and (4) patient navigation tools to mitigate clinic-level challenges.
No Intervention: Enhanced treatment as usual; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the intervention	Feasibility will be demonstrated if all three are met by participants: (1) 50% of participants who are approached choose to enroll; (2) 70% of participants complete the intervention; and (3) 60% complete the 3-month follow-up. Feasibility of the implementation of the intervention will be explored in interviews with providers and clinic staff. To assess fidelity, each intervention session with be audio recorded; an assessor will review 20% of the session transcripts and determine whether all key session themes were addressed using checklists developed by the study team for the intervention.	About 1 month after the start of intervention and at about 3 months after the start of the intervention
Acceptability of the intervention	Acceptability will be measured using the seven component constructs of the acceptability of health care interventions framework using a five-point Likert style scale. The seven components include affective attitude (i.e., how an individual feels about the intervention), burden, ethicality (i.e., the extent to which the intervention aligns with one's value system), intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. Acceptability will be demonstrated if, on average, at least 75% of the participants rate five or more of the items on the eight-item Acceptability of Healthcare Interventions Questionnaire with a 4 or a 5 on the Likert-style scale. Acceptability of the intervention will also be explored in interviews with providers, clinic staff, interventionalists, and other relevant stakeholders.	About 1 month after the start of intervention and at about 3 months after the start of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follow-up appointment attendance	This will be measured by comparing the proportions between intervention and ETAU groups at the end of the intervention and the three-month follow-up visit.	about 1 month after the start of intervention and about 3 months after the start of the intervention
Self-efficacy to attend cervical cancer-related health care appointment	This will be measured by comparing change in scores from baseline, post-intervention, and the three-month follow-up visit between the intervention and ETAU groups. The maximum score is 35 and the minimum score is 7, with higher scores indicating more self-efficacy.	At the start of the intervention, about 1 month after the start of intervention, and at about 3 months after the start of the intervention

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Collaborators: Massachusetts General Hospital; University of Witwatersrand, South Africa
• Investigators: Principal Investigator: Amelia Stanton, PhD, Boston University Charles River Campus

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 24, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Uterine Diseases; Genital Diseases, Female; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Genital Neoplasms, Female; Slow Virus Diseases; Uterine Cervical Diseases; Uterine Neoplasms; HIV Infections; Acquired Immunodeficiency Syndrome; Uterine Cervical Neoplasms
• Other Study ID Numbers: 7356E

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No