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Universal Coverage of Antiretroviral Treatment in Senegal

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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

Tracking Information
First Submitted Date  ICMJE June 20, 2017
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date March 19, 2019
Actual Study Start Date  ICMJE June 5, 2017
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Universal Coverage of Antiretroviral Treatment in Senegal
Official Title  ICMJE Leveraging Adaptive Implementation Strategies to Achieve Universal Coverage of Antiretroviral Treatment in Senegal
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.
Detailed Description

The overarching goal of this study is to assess the feasibility, fidelity, and cost-effectiveness of a universal coverage of Antiretroviral Treatment (ART) intervention among individuals living with HIV who are not virally suppressed in Dakar and Ziguinchor, Senegal. Specific aims and hypotheses are as follows:

Specific Aim 1: Compare the effectiveness and durability of (a) the existing Standard of Care (SOC) in Senegal versus (b) individual Case Management (CM) programs to achieve sustained viral suppression (SVS) among people living with HIV in Senegal.

Hypothesis 1: The null hypothesis is that standard of care and case management will be equally effective at achieving sustained viral suppression. The alternate hypothesis is that case management will be 30% more effective at sustained viral suppression at 12 months compared to standard of care.

Specific Aim 2: Determine the cost-effectiveness of the universal treatment approach using the CM intervention.

Hypothesis 1: A Case Management approach will be more cost-effective at achieving sustained viral suppression among people living with HIV (PLHIV) versus the existing standard of care in Senegal.

This study is a randomized controlled trial (RCT) that uses an effectiveness-implementation hybrid design to test the effectiveness and durability of CM interventions in achieving SVS among PLHIV who are not virally suppressed. CM vs. SOC approaches will be assessed using an individual-level RCT of case management to improve viral suppression of those living with HIV at 12 months compared to the Senegal SOC. While viral suppression will be a primary outcome of this intervention, significant attention will be given to the collection of service and implementation outcomes to assess both the SOC and CM.

Study sites will include two government HIV treatment facilities in Ziguinchor, and two in Dakar. Participant enrollment into the study will take place at the study sites, and study arms (SOC or CM) will be assigned through individual randomization at the clinic level. Notably, the HIV treatment facilities in this study are existing government facilities given the partnership between this study and the Ministry of Health (MOH) of Senegal.

Eligible participants recruited through the study site health facilities will go through the consent process in private rooms within the project office and complete a structured 1-hour interviewer-administered questionnaire, which will serve as the baseline assessment. Participants will be enrolled into the study, by trained study staff at a study site.

Baseline assessment of study participants will include a socio-behavioral questionnaire and biological testing. The baseline questionnaire will assess demographic characteristics, socioeconomic status, mobility and migration history, behavioral characteristics, health and HIV treatment history, and HIV acquisition risks.

Follow up will involve visits at 3, 6, 9, and 12 months after the first visit. Questionnaires will be administered at each visit. Questionnaires assessing behavioral characteristics, mental health, social support, and ART treatment adherence will be administered at 6 months, and 12 months.

Abbreviated questionnaires will be re-administered at 3 and 9 months though no biological assessments will be completed at these time points. The questionnaires leverage existing instruments that have detailed assessments engagement in ART services as well as enacted, perceived, and intersectional stigma. In addition, the investigators will use implementation indicators that explore measures of acceptability, fidelity, appropriateness, and routinization of the CM intervention.

Biological samples using either aliquots of serum or dried blood spots (DBS) will be taken at baseline, 6 months, and 12 months to support syphilis testing, HIV viral load, and other sexually transmitted infections (STIs). 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE HIV/AIDS
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Case management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2019)
596
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Carrie Lyons, MPH 4432875665 clyons8@jhu.edu
Contact: Gnilane Turpin, BA 4432875129 gturpin@jhu.edu
Listed Location Countries  ICMJE Senegal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03880006
Other Study ID Numbers  ICMJE IRB00007193
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins Bloomberg School of Public Health
Study Sponsor  ICMJE Johns Hopkins Bloomberg School of Public Health
Collaborators  ICMJE
  • United States Agency for International Development (USAID)
  • ENDA Sante, Senegal
  • Ministry of Health, Senegal
  • Population Council
Investigators  ICMJE
Principal Investigator: Stefan Baral, MD MPH Johns Hopkins Bloomberg School of Public Health
PRS Account Johns Hopkins Bloomberg School of Public Health
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP