HIV/AIDSNCT03880006
Universal Coverage of Antiretroviral Treatment in Senegal
A study testing Case management in people with HIV/AIDS, run by Johns Hopkins Bloomberg School of Public Health at 4 sites in Senegal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Case management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 596 participants
- Where
- 4 sitesSenegal
- Study dates
- 5 Jun 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Senegal4 sites
Institut d'hygiene sociale / polyclinique
Dakar
Centre de sante Dominique
Pikine
Hopital regional de Ziguinchor
Ziguinchor
Hopital Silence de Ziguinchor
Ziguinchor
About this study
Official title: Leveraging Adaptive Implementation Strategies to Achieve Universal Coverage of Antiretroviral Treatment in Senegal
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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- Case management
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case managementBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Case management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Viral suppression at 12 months of follow up
Secondary outcomes (3)
Loss-to-follow-up of study participation among study participants
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.
Measured: Loss to follow up at 12 months
Acceptability of CM intervention among study participants through self-reported measure.
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.
Measured: 12 months
Cost-effectiveness of the universal treatment approach using the CM intervention
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start5 Jun 2017
- Primary completion1 Mar 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), ENDA Sante, Senegal, Ministry of Health, Senegal, Population Council
- Responsible party
- Sponsor
- Investigators
- Stefan Baral, MD MPH, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880006
- Sponsor's protocol ID
- IRB00007193
- Status last verified
- Oct 2022
- First submitted
- 20 Jun 2017
- Last updated
- 7 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Adaptive Implementation Strategies to Achieve Universal Coverage of Antiretroviral Treatment in Senegal
- ClinicalTrials.gov ID
- NCT03880006
- Acronym / sponsor ID
- IRB00007193
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), ENDA Sante, Senegal, Ministry of Health, Senegal, Population Council
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Participants assigned to the Senegalese standard of care treatment for people living with HIV. |
| Case management | Experimental | Behavioral: Case managementIndividuals in the intervention arm will receive Senegalese standard of care treatment for people living with HIV, and the case management intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case managementCase 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. | Behavioural | Case management |
Primary outcome
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
3 secondary outcomes
Loss-to-follow-up of study participation among study participants
Time frame: Loss to follow up at 12 months
Acceptability of CM intervention among study participants through self-reported measure.
Time frame: 12 months
Cost-effectiveness of the universal treatment approach using the CM intervention
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Baral, MD MPH principal investigator
Johns Hopkins Bloomberg School of Public Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case management in people with HIV/AIDS, run by Johns Hopkins Bloomberg School of Public Health at 4 sites in Senegal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.