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Universal Coverage of Antiretroviral Treatment in Senegal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03880006
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
ENDA Sante, Senegal
Ministry of Health, Senegal
Population Council
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Case management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 596 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Leveraging Adaptive Implementation Strategies to Achieve Universal Coverage of Antiretroviral Treatment in Senegal
Actual Study Start Date : June 5, 2017
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: Standard of care
Participants assigned to the Senegalese standard of care treatment for people living with HIV.
Experimental: Case management
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
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.




Primary Outcome Measures :
  1. Viral suppression among study participants measured through biological samples using either aliquots of serum or dried blood spots (DBS). [ Time Frame: Viral suppression at 12 months of follow up ]

    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



Secondary Outcome Measures :
  1. Loss-to-follow-up of study participation among study participants [ Time Frame: Loss to follow up at 12 months ]
    Numbers and proportions of participants remaining engaged in the study will be measured through study visits every 3 months. Loss to follow up among participants in the existing Standard of Care study arm will be compared to the individual Case Management (CM) study arm to measure a difference in loss to follow up between the two study arms.

  2. Acceptability of CM intervention among study participants through self-reported measure. [ Time Frame: 12 months ]
    Acceptability of the CM intervention will be measured through self-reported measures collected through the social behavioral questionnaire. Acceptability measure is leveraged from the Society of Implementation Research Collaboration instrument review.

  3. Cost-effectiveness of the universal treatment approach using the CM intervention [ Time Frame: 12 months ]
    To determine the cost-effectiveness of the universal treatment approach using the CM intervention, we will perform a comprehensive costing of our study intervention, from the perspectives of both the healthcare system and the participants. Our costing methodology will follow World Health Organization (WHO) recommendations for cost-effectiveness analysis, with estimates of unit costs compared against WHO's CHOosing Interventions that are Cost-Effective (CHOICE) global estimates for countries in Senegal's region.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880006


Contacts
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Contact: Carrie Lyons, MPH 4432875665 clyons8@jhu.edu
Contact: Gnilane Turpin, BA 4432875129 gturpin@jhu.edu

Locations
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Senegal
Institut d'hygiene sociale / polyclinique Not yet recruiting
Dakar, Senegal
Contact: Cheikh Tidiane Ndour, MD Msc         
Centre de sante Dominique Recruiting
Pikine, Senegal
Contact: Daouda Diouf, Msc         
Principal Investigator: Daouda Diouf, Msc         
Hopital regional de Ziguinchor Not yet recruiting
Ziguinchor, Senegal
Contact: Daouda Diouf, Msc         
Hopital Silence de Ziguinchor Not yet recruiting
Ziguinchor, Senegal
Contact: Daouda Diouf, Msc         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
United States Agency for International Development (USAID)
ENDA Sante, Senegal
Ministry of Health, Senegal
Population Council
Investigators
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Principal Investigator: Stefan Baral, MD MPH Johns Hopkins Bloomberg School of Public Health
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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT03880006    
Other Study ID Numbers: IRB00007193
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases