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 (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).

Study Overview

• Status: Not yet 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
      • Contact: Jennifer Smit, PhD; Phone Number: +27 (0)31 001 1904; Email: jsmit@mru.ac.za
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
      • Contact: Christina Psaros, PhD; Email: Cpsaros@mgh.harvard.edu
      • Contact: Courtney Yuen, PhD; Email: Courtney_Yuen@hms.harvard.edu
    • Boston, Massachusetts, United States, 02215
      • Boston University

Participation Criteria

Eligibility Criteria

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

Description

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.

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
No Intervention: Treatment as usual; The treatment as usual (TAU) group will receive treatment as usual, including being notified of their abnormal Pap results via SMS and instructed to set up a follow-up appointment, as is typical in routine care. The TAU group will complete the T1 assessment and will complete T2 assessment two-months post-baseline.
Experimental: Participant intervention; The intervention group will likely consist of one to two sessions, conducted in-person, coupled with text- or phone-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 up to 6 SMS messages (one-way) per month. The content of these messages will be developed collaboratively between the participant and the interventionist during the second 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; Aim 1 data will inform this intervention, however the participant intervention will likely be one or two sessions, conducted in-person, coupled with text- or phone-based client navigation with women who received abnormal high-risk Pap smear results. We anticipate that the intervention may integrate (1) information to improve awareness of cervical cancer susceptibility and treatment, (2) motivational interviewing to assess pros and cons of attending a follow-up appointment and completing treatment; (3) brief cognitive behavioral therapy (CBT) skills to reduce individual-level barriers, (4) problem-solving to increase social support, and (5) patient navigation tools to mitigate clinic-level challenges.

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, clinic staff, interventionalists, and other relevant stakeholders.	About 1-2 months after the start of intervention and at about 4 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 1-2 months after the start of intervention and at about 4 months after the start of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy to attend cervical cancer-related health care appointment	This will be measured by comparing change scores from baseline to post-intervention between the intervention and TAU groups.	Start of the intervention and about 1-2 months after the start of intervention
Follow-up appointment attendance	This will be measured by comparing the proportions between intervention and TAU groups.	About 4 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

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 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 (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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