Universal Coverage of Antiretroviral Treatment in Senegal

NCT03880006 | Completed

• 1 other identifier: IRB00007193
• Study Type: interventional
• Target: 596
• Locations: 1 country
• Sites: 4

Brief Summary

Senegal plans a rapid scale up of HIV treatment for all people living with HIV, regardless of cluster of differentiation 4 (CD4) count or viral suppression. However, limited data exist on how to achieve sustained viral suppression outside of a controlled setting, and with significant barriers to effective antiretroviral therapy delivery, uptake, and adherence. The purpose of this study is to develop and assess the feasibility, fidelity, and cost-effectiveness of a universal coverage of Antiretroviral Treatment (ART) intervention among people living with HIV who are not virally suppressed in Dakar and Ziguinchor, Senegal.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• Viral suppression among study participants measured through biological samples using either aliquots of serum or dried blood spots (DBS).

  Biological samples using either aliquots of serum or dried blood spots will be taken at baseline, 6 months, and 12 months to support HIV viral load testing. Biological testing taken at baseline and will include testing currently being implemented through the SOC, and testing conducted at the additional visits will be supported by the study. All participants will also have the opportunity to receive referrals for additional medical care as needed at the clinics in which the study sites are housed. Sustained viral suppression is defines as quantitative viral load assessment with \<1000 copies/ml at 12 months after initial randomization

  Viral suppression at 12 months of follow up

Secondary Outcomes (3)

• Loss-to-follow-up of study participation among study participants

  Loss to follow up at 12 months

• Acceptability of CM intervention among study participants through self-reported measure.

  12 months

• Cost-effectiveness of the universal treatment approach using the CM intervention

  12 months

Study Arms (2)

Standard of care

NO INTERVENTION

Participants assigned to the Senegalese standard of care treatment for people living with HIV.

Case management

EXPERIMENTAL

Individuals in the intervention arm will receive Senegalese standard of care treatment for people living with HIV, and the case management intervention.

Behavioral: Case management

Interventions

Case management BEHAVIORAL

Case management intervention is a multi-step process to coordinate care and provide a family-like support system for people living with HIV. Individuals are assigned to a specific case manager who will provide support throughout the study. The case management approach has five key components: 1) initial meeting between person living with HIV and case manager; 2) follow up meeting between case manager and participant; 3) biweekly automatic text messages sent to participant; 4) monthly phone calls from case manager; and 5) face-to-face meetings between case manager and participant every 6 months.

Case management

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Is mentally sound and capable of providing consent to participate
• Agrees to complete HIV and syphilis testing
• Speaks either French, Wolof or both
• Has provided informed consent to participate in the study
• Resident of Senegal for the past 3 months
• Intention to live in Dakar or Ziguinchor for the next 12 months
• Agrees to complete all required biological testing described in the consent form and receive results

You may not qualify if:

• Under 18 years of age
• Demonstrates mental incapacity, under the influence of substances, or any other illness preventing comprehension of the study procedures and informed consent
• Does not agree to complete all required biological testing described in the consent form or receive results
• Has not provided informed consent to participate in the study

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• United States Agency for International Development (USAID): collaborator
• ENDA Sante, Senegal: collaborator
• Ministry of Health, Senegal: collaborator
• Population Council: collaborator

Study Sites (4)

Institut d'hygiene sociale / polyclinique

Dakar, Senegal

Location

Centre de sante Dominique

Pikine, Senegal

Location

Hopital regional de Ziguinchor

Ziguinchor, Senegal

Location

Hopital Silence de Ziguinchor

Ziguinchor, Senegal

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Case Management

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; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Stefan Baral, MD MPH

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: March 19, 2019
• Study Start: June 5, 2017
• Primary Completion: March 1, 2020
• Study Completion: June 30, 2020
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)