HIV (Human Immunodeficiency Virus)PARCNCT01992887
Pre-ART Retention in Care in Tanzania
An observational study of HIV (Human Immunodeficiency Virus) and AIDS (Acquired Immunodeficiency Syndrome), run by Columbia University at 4 sites in Tanzania.
Trial summary
Retention of patients in HIV care following diagnosis and enrollment is critical to the long-term success of HIV care and treatment scale-up. The goal of this study is to better understand the factors that influence retention and engagement in HIV care among adult patients who are enrolled in HIV care and are not yet… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV (Human Immunodeficiency Virus), AIDS (Acquired Immunodeficiency Syndrome)
- How many people
- 948 participants
- Where
- 4 sitesTanzania
- Study dates
- Mar 2012to Feb 2016
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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
Study population: Participants will be recruited at four HIV CTCs in the Kagera region of northwestern Tanzania. The 8,000 patients enrolled in HIV care at these clinics represent 30% of HIV patients ever enrolled in ICAP-supported clinics across Kagera Region. Patients will be eligible for selection for either in-depth interviews or focus group discussions if they have made at least one prior visit to the clinic.
QUALITATIVE COHORT
In-depth key informant interviews and focus groups will be conducted with patients that meet the following criteria:
ART-eligibility indeterminate patients (n= approximately 10 in-depth and up to 20 focus group participants, where half are from a rural site, Mugana District Hospital and half are from an urban site, Nyakahanga District Hospital)
- Inclusion criteria:
- ≥18 years of age
- ART naïve (unless for prior PMTCT)
- made at least one clinic visit prior to study enrollment
- unknown ART eligibility,
- willing to give informed consent. ii) Exclusion criteria:
- <18 years of age
- initiated ART other than PMTCT prior to enrollment
- have known ART eligibility or ineligibility
- not willing to give informed consent.
ART-ineligible patients (n= approximately 10 in-depth and up to 20 focus group participants, where half are from a rural site, Mugana District Hospital and half are from an urban site, Nyakahanga District Hospital)
- Inclusion criteria:
- ≥18 years of age
- ART naïve (unless for prior PMTCT)
- made at least one clinic visit prior to study enrollment
- known ART ineligibility
- willing to give informed consent. ii) Exclusion criteria:
- <18 years of age
- initiated ART other than PMTCT prior to enrollment
- have known ART eligibility
- not willing to give informed consent
Health care workers will be purposefully selected for participation according to the following criteria:
- Inclusion criteria:
- ≥18 years of age
- have worked at that HIV clinic more than any other post within the hospital for at least 6 months
- medical officer, clinical officer or nurse
- willing to give informed consent. ii) Exclusion criteria:
- <18 years of age
- primarily posted at another clinic (just part-time or tempory assignment to HIV clinic)
- not willing to give informed consent
PROSPECTIVE COHORT
Patients that meet the following criteria will be included in the prospective study cohort:
- Inclusion criteria:
- ≥18 years of age
- ART naïve (unless for prior PMTCT)
- enrolled in the study CTC
- ART-ineligible or of indeterminate ART eligibility
- willing to provide written informed consent,contact information and accept a home visit to verify outcomes if they become LTF. ii) Exclusion criteria:
- <18 years of age
- initiated ART other than PMTCT prior to study enrollment
- ART eligible
- and/ or not willing to provide written informed consent, contact information or accept a home visit if LTF.
Trial locations and contacts
4 sites in 1 country.
Tanzania4 sites
Ndolage District Hospital
Kamachumu, Kagera
Mugana District Hospital
Mugana, Kagera
Nyakahanga District Hospital
Nyakahanga, Kagera
Rubya District Hospital
Rubya, Kagera
About this study
Official title: Retention and Engagement in Care of Patients Prior to ART Initiation in the Kagera Region of Tanzania
Retention of patients in HIV care following diagnosis and enrollment is critical to the long-term success of HIV care and treatment scale-up. The goal of this study is to better understand the factors that influence retention and engagement in HIV care among adult patients who are enrolled in HIV care and are not yet eligible for antiretroviral therapy (ART). The study will be conducted at four HIV care and treatment clinics (CTCs) in Kagera Region, Tanzania. This is a mixed-methods study with both qualitative (interviews) and quantitative (surveys) data collection. Our findings will be important towards designing programs that help patients remain in HIV care.
Read the detailed description
Retention of patients in HIV care following diagnosis and enrollment is a chronic challenge in both resource rich and resource poor settings (Rosen, Fox et al. 2007; WHO 2009; Fox and Rosen 2010), and is critical to the long-term success of HIV care and treatment scale-up. Most research on retention in care has focused on persons who are eligible for or have initiated antiretroviral therapy (ART), generally examined only demographic and clinical determinants. However, a large proportion of patients enrolled in HIV care (e.g., 45%, according to our data from 722 sub-Saharan African clinics) have not been determined to be ART-eligible and have not yet initiated ART; among these individuals, even less is known about the magnitude and determinants of non-retention in care. Retention in HIV care prior to ART initiation is a pre-requisite to: 1) optimal prophylaxis, diagnosis, and treatment of opportunistic illnesses (OIs); 2) effective secondary prevention of HIV transmission, such as by patient counseling and education, earlier diagnosis of infected family members and sexual partners, and prevention of mother to child transmission (PMTCT); and 3) more timely ART initiation. Retention in care among patients at earlier disease stages is also increasingly important given the WHO-recommended expansion of ART eligibility guidelines in resource-limited settings (WHO 2009).
Objective: The goal of this study is to better understand barriers and enablers to retention and engagement in HIV care among adult patients who are enrolled in HIV care and are not yet eligible for ART. The specific objectives are:
- To describe themes in barriers and enablers to retention and engagement in HIV care;
- To conduct structured interviews to gather relevant baseline information on potential determinants of non-retention and non-engagement in HIV care;
- To estimate the incidence of short-term outcomes (missed visits and lost to follow-up (LTF)), including the rate and proportion of those LTF who are no longer engaged in HIV care; and
- To identify determinants of missed visits, LTF, and non-engagement in care among ART-ineligible patients.
Methods: This study will be conducted using qualitative and quantitative methods at four HIV care and treatment clinics (CTCs) in Kagera Region, Tanzania.
- Qualitative: in-depth interviews at two CTCs with up to 20 adult patients (ART naïve, and ineligible or indeterminate for ART) and about 4 health care workers; and focus group discussions (about 4 groups of about 6-10 persons/group) with adult patients (ART naïve, and ineligible or indeterminate for ART).
- Quantitative: 1) structured baseline interviews at four CTCs (n= approximately 900 adult patients who are ART naïve, and ineligible or indeterminate for ART); 2) prospective monitoring of these 900 patients using routine CTC patient data to assess missed visits and LTF; and 4) brief structured surveys of patients who become LTF and are reached through defaulter tracing efforts.
- Keywords
- HIV/AIDS, Retention, ART (anti-retroviral therapy) ineligible
- 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.
| Study group | Role | What they receive |
|---|---|---|
| In-depth Interview | Up to 20 in-depth interviews will be conducted among adult ART naïve patients, balanced by gender, site and reason for ART naiveté (determined ineligible or eligibility not yet determined) as much as possible. Up to 4 in-depth interviews will be conducted with health care providers. | |
| Focus Group Participants | Up to 40 patients ineligible or not yet eligible for ART will be invited to join a focus group discussion. Patients will be eligible for selection for either in-depth interviews or focus group discussions if they have made at least one prior visit to the clinic. Selected patients will be balanced as much as possible by gender and by pre-ART status (e.g. roughly half pre-ART eligibility determined, and roughly half pre-ART eligibility indeterminate). | |
| Prospective Cohort | Based on historical patient data from the four study CTCs, we expect that approximately 1,000 patients will enroll in HIV care at these clinics during the study period and be determined not eligible for ART or of unknown eligibility. Assuming a 10% refusal rate, approximately 900 patients would then enroll in this study and complete baseline interviews. These 900 patients will be prospectively monitored using routinely collected patient care data for up to 24 months. Outreach workers will attempt to trace all of the enrolled patients who are observed to be LTF during the study period, and complete a defaulter tracing survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of those lost to follow-up (LTF) who are no longer engaged in HIV care
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startMar 2012
- Primary completionAug 2014
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 948 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Social Welfare, Tanzania, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Batya Elul, Columbia University
- Investigators
- Batya Elul, PhD, MSc, Principal investigator, ICAP-NY, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992887
- Sponsor's protocol ID
- AAAI0251
- Other IDs
- 3R01MH089831
- Acronym
- PARC
- Status last verified
- May 2016
- First submitted
- 8 Nov 2013
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Fox MP, Rosen S. Patient retention in antiretroviral therapy programs up to three years on treatment in sub-Saharan Africa, 2007-2009: systematic review. Trop Med Int Health. 2010 Jun;15 Suppl 1(s1):1-15. doi: 10.1111/j.1365-3156.2010.02508.x.
PubMed 20586956Rosen S, Fox MP, Gill CJ. Patient retention in antiretroviral therapy programs in sub-Saharan Africa: a systematic review. PLoS Med. 2007 Oct 16;4(10):e298. doi: 10.1371/journal.pmed.0040298.
PubMed 17941716Antiretroviral Therapy for HIV Infection in Adults and Adolescents: Recommendations for a Public Health Approach: 2010 Revision. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138540/
PubMed 23741771WHO (2009). Towards Universal Access: Scaling up priority HIV/AIDS Interventions in the Health Sector: Progress report 2009. Geneva, WHO.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention and Engagement in Care of Patients Prior to ART Initiation in the Kagera Region of Tanzania
- ClinicalTrials.gov ID
- NCT01992887
- Acronym / sponsor ID
- PARC / AAAI0251
- Keywords
- HIV/AIDS, Retention, ART (anti-retroviral therapy) ineligible
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 948 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health and Social Welfare, Tanzania, National Institute of Mental Health (NIMH)
- Study start
- Mar 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 25 Nov 2013 (estimated)
- 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.
Retention of patients in HIV care following diagnosis and enrollment is critical to the long-term success of HIV care and treatment scale-up. The goal of this study is to better understand the factors that influence retention and engagement in HIV care among adult patients who are enrolled in HIV care and are not yet eligible for antiretroviral therapy (ART). The study will be conducted at four HIV care and treatment clinics (CTCs) in Kagera Region, Tanzania. This is a mixed-methods study with both qualitative (interviews) and quantitative (surveys) data collection. Our findings will be important towards designing programs that help patients remain in HIV care.
Detailed description
Retention of patients in HIV care following diagnosis and enrollment is a chronic challenge in both resource rich and resource poor settings (Rosen, Fox et al. 2007; WHO 2009; Fox and Rosen 2010), and is critical to the long-term success of HIV care and treatment scale-up. Most research on retention in care has focused on persons who are eligible for or have initiated antiretroviral therapy (ART), generally examined only demographic and clinical determinants. However, a large proportion of patients enrolled in HIV care (e.g., 45%, according to our data from 722 sub-Saharan African clinics) have not been determined to be ART-eligible and have not yet initiated ART; among these individuals, even less is known about the magnitude and determinants of non-retention in care. Retention in HIV care prior to ART initiation is a pre-requisite to: 1) optimal prophylaxis, diagnosis, and treatment of opportunistic illnesses (OIs); 2) effective secondary prevention of HIV transmission, such as by patient counseling and education, earlier diagnosis of infected family members and sexual partners, and prevention of mother to child transmission (PMTCT); and 3) more timely ART initiation. Retention in care among patients at earlier disease stages is also increasingly important given the WHO-recommended expansion of ART eligibility guidelines in resource-limited settings (WHO 2009).
Objective: The goal of this study is to better understand barriers and enablers to retention and engagement in HIV care among adult patients who are enrolled in HIV care and are not yet eligible for ART. The specific objectives are:
- To describe themes in barriers and enablers to retention and engagement in HIV care;
- To conduct structured interviews to gather relevant baseline information on potential determinants of non-retention and non-engagement in HIV care;
- To estimate the incidence of short-term outcomes (missed visits and lost to follow-up (LTF)), including the rate and proportion of those LTF who are no longer engaged in HIV care; and
- To identify determinants of missed visits, LTF, and non-engagement in care among ART-ineligible patients.
Methods: This study will be conducted using qualitative and quantitative methods at four HIV care and treatment clinics (CTCs) in Kagera Region, Tanzania.
- Qualitative: in-depth interviews at two CTCs with up to 20 adult patients (ART naïve, and ineligible or indeterminate for ART) and about 4 health care workers; and focus group discussions (about 4 groups of about 6-10 persons/group) with adult patients (ART naïve, and ineligible or indeterminate for ART).
- Quantitative: 1) structured baseline interviews at four CTCs (n= approximately 900 adult patients who are ART naïve, and ineligible or indeterminate for ART); 2) prospective monitoring of these 900 patients using routine CTC patient data to assess missed visits and LTF; and 4) brief structured surveys of patients who become LTF and are reached through defaulter tracing efforts.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In-depth Interview | – | –Up to 20 in-depth interviews will be conducted among adult ART naïve patients, balanced by gender, site and reason for ART naiveté (determined ineligible or eligibility not yet determined) as much as possible. Up to 4 in-depth interviews will be conducted with health care providers. |
| Focus Group Participants | – | –Up to 40 patients ineligible or not yet eligible for ART will be invited to join a focus group discussion. Patients will be eligible for selection for either in-depth interviews or focus group discussions if they have made at least one prior visit to the clinic. Selected patients will be balanced as much as possible by gender and by pre-ART status (e.g. roughly half pre-ART eligibility determined, and roughly half pre-ART eligibility indeterminate). |
| Prospective Cohort | – | –Based on historical patient data from the four study CTCs, we expect that approximately 1,000 patients will enroll in HIV care at these clinics during the study period and be determined not eligible for ART or of unknown eligibility. Assuming a 10% refusal rate, approximately 900 patients would then enroll in this study and complete baseline interviews. These 900 patients will be prospectively monitored using routinely collected patient care data for up to 24 months. Outreach workers will attempt to trace all of the enrolled patients who are observed to be LTF during the study period, and complete a defaulter tracing survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited at four HIV CTCs in the Kagera region of northwestern Tanzania. The 8,000 patients enrolled in HIV care at these clinics represent 30% of HIV patients ever enrolled in ICAP-supported clinics across Kagera Region. Patients will be eligible for selection for either in-depth interviews or focus group discussions if they have made at least one prior visit to the clinic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of those lost to follow-up (LTF) who are no longer engaged in HIV care
Time frame: 24 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 13 May 2016.
- Background: PubMed 20586956Fox MP, Rosen S. Patient retention in antiretroviral therapy programs up to three years on treatment in sub-Saharan Africa, 2007-2009: systematic review. Trop Med Int Health. 2010 Jun;15 Suppl 1(s1):1-15. doi: 10.1111/j.1365-3156.2010.02508.x.
- Background: PubMed 17941716Rosen S, Fox MP, Gill CJ. Patient retention in antiretroviral therapy programs in sub-Saharan Africa: a systematic review. PLoS Med. 2007 Oct 16;4(10):e298. doi: 10.1371/journal.pmed.0040298.
- Background: PubMed 23741771Antiretroviral Therapy for HIV Infection in Adults and Adolescents: Recommendations for a Public Health Approach: 2010 Revision. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138540/
- BackgroundWHO (2009). Towards Universal Access: Scaling up priority HIV/AIDS Interventions in the Health Sector: Progress report 2009. Geneva, WHO.
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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.
Batya Elul, PhD, MSc principal investigator
ICAP-NY, Columbia University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV (Human Immunodeficiency Virus) and AIDS (Acquired Immunodeficiency Syndrome), run by Columbia University at 4 sites in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 May 2016. 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 Tanzania. 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?
Proportion of those lost to follow-up (LTF) who are no longer engaged in HIV care (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01992887, which also lists 4 linked publications.
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 13 May 2016.