Early Community Client-LED ART Delivery in Nakivale Refugee Settlement

NCT04736316 | Completed Results DMC

• 2 other identifiers: STUDY00008718K23MH108440
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

To pilot early community client-led ART (anti-retroviral therapy) delivery (CCLAD) in Nakivale Refugee Settlement in Uganda and assess the feasibility and acceptability of this intervention in this setting.

Conditions

HIV Seropositivity

Outcome Measures

Primary Outcomes (10)

• Number of Participants in HIV Care (Linkage) Among the Early CCLAD Participants

  Attendance in one Early CCLAD group meeting (yes/no)

  Within 90 days of study initiation excluding the day of diagnosis

• Number of Early CCLAD Group Visits Attended (Retention) Among Early CCLAD Participants

  Attendance in monthly Early CCLAD group meetings (yes/no). With an intention to treat, description of how many monthly group meetings were attended in the first 6 months of the intervention including Early CCLAD community visits, but not including HIV clinic visits

  6 months

• ART Initiation

  Number of participants who picked up anti-retroviral therapy (ART) at least once over the 6 month period as documented in the written HIV clinic record

  6 months

• Clinical Outcomes: Number of Participants With Viral Suppression

  Viral suppression defined by \<1000 copies/mL or CD4 count \>250 cells/mm3 as documented in the HIV clinic records

  6 month period

• Total Number of Clinic Visits Per Participant (Incl. CCLAD Visits)

  All clinic and CCLAD visits per participant

  6 months

• Survey Score Related to Psychosocial Factors: Perceived Health

  Question: "In general, would you say your health is excellent, very good, good, fair or poor?" Answer options: "Excellent, very good, good, fair, poor, do not know, no answer" This is among participants who completed both baseline and follow-up surveys only.

  baseline survey and 6 month follow-up survey

• Survey Score Related Factors: Screened Positive for Depression

  Depression measured via Patient health questionnaire depression assessment (PHQ-9); 9 questions with 0-3 score for each answer. Interpretation of score: 0-4= minimal or no depression; 5-9= mild depression; 10-14=moderate depression. For this study, we considered a positive screen for depression as a PHQ-9 score of \>=10. This analysis includes only those who participated in baseline and 6 month surveys.

  baseline and 6 month surveys

• Survey Score Related Factors: Screened Positive for Anxiety

  Anxiety measured via Generalized anxiety disorder (GAD-7) tool; 7 questions with 0-3 score for each answer; Interpretation of total score: 0-4=minimal anxiety; 5-9= mild anxiety; 10-14=moderate anxiety; 15-21=severe anxiety. For this study, those with a score of \>= 10 were considered to have screened in for anxiety. This analysis includes only those who participated in baseline and 6 month surveys.

  Baseline and 6 months

• Survey Score Related Factors: Screening Positive for PTSD

  PTSD measured via Post-traumatic stress disorder (PCL-6) scale; 6 questions with 1-5 score for each question; Interpretation of Total score: greater than or equal to 14 is a positive screen. This analysis includes only those who participated in baseline and 6 month surveys.

  baseline and 6 month surveys

• Survey Score Related Factors: Screening Positive for Low of Social Support

  Social Support measured via Social support (BS6) scale; 6 questions with scores 1-4 for each answer; Interpretation of total score: 6-11= low (a positive screen for lack of social support), 12-17=moderate (at least occasional support); 18-23= high; 24=very high (maximum, always supported). For this study we considered \<= 11 as a positive screen for low of social support. This analysis includes only those who participated in baseline and 6 month surveys.

  baseline and 6 month surveys

Study Arms (1)

Early CCLAD

EXPERIMENTAL

Early community client-led ART delivery groups

Behavioral: Early CCLAD

Interventions

Early CCLAD BEHAVIORAL

Community-based client led antiretroviral therapy delivery groups.

Early CCLAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years of age who present to the Nakivale Health Center and agree/consent to test for HIV.

You may not qualify if:

• Unable to understand one of the study languages (English, Kinyarwanda, Kiswahili, Runyankore).
• Subjects who do not test positive for HIV at health center will not be eligible to participate in the early community-based client-led antiretroviral therapy delivery intervention

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Nakivale Refugee Settlement

Isingiro, Uganda

Location

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Kelli O'Laughlin
• Organization: University of Washington

kolaugh@uw.edu

206-744-2559

Study Officials

• Kelli N O'Laughlin, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: February 3, 2021
• Study Start: June 29, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: July 11, 2023
• Results First Posted: July 11, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)