HIV InfectionsPhase 3eASPNCT00408642
An Enhanced Adherence Support Programme for Highly Active Antiretroviral Therapy (HAART)
A Phase 3 study testing Enhanced adherence support and Standard adherence support in people with HIV Infections, run by Centre for the AIDS Programme of Research in South Africa at 1 site in South Africa.
Trial summary
In southern Africa, TB is the most common first AIDS-defining condition. Initiating Antiretroviral therapy (ART) in HIV positive TB patients will lead to the inclusion of the majority of HIV/AIDS patients currently fulfilling the criteria for therapy. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Enhanced adherence support and Standard adherence support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 1 siteSouth Africa
- Study dates
- Aug 2007to Mar 2011
- Phase
- Phase 3
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients enrolled in the CAPRISA CAT programme and the CDC.
- Willing and able to provide written consent to take part in the study.
- > 18 years of age (to give consent for participation)
- Eligible for initiation of HAART (currently CD4+ <200)
Who cannot join
- Unwillingness or inability to adhere to the study schedule
Trial locations and contacts
1 site in 1 country.
South Africa1 site
CAPRISA eThekwini Clinical Research Site
Durban, KwaZulu-Natal, 4001
About this study
Official title: An Enhanced Adherence Support Programme for HAART
In southern Africa, TB is the most common first AIDS-defining condition. Initiating Antiretroviral therapy (ART) in HIV positive TB patients will lead to the inclusion of the majority of HIV/AIDS patients currently fulfilling the criteria for therapy. Establishing an effective intervention to increase treatment adherence in this group is essential for the successful roll out of ART in the region. This proposed randomized controlled study aims to compare the effectiveness of two adherence support programmes (ASP) for use in patients with HIV-related TB in the context of CAPRISA AIDS Treatment (CAT)programme in KwaZulu-Natal, South Africa; the enhanced adherence support programme (E-ASP) or the standard adherence support programme (S-ASP).
S-ASP consists of three counselor presented, group education sessions. E-ASP is an extension of S-ASP and is based on the Information-Motivation-Behavioral Skills (IMB) Model of Adherence to Antiretroviral Therapy, a theoretical model initially developed to reduce HIV risk behavior. The E-ASP will consist of several interconnected components: 1) development and maintenance of an educational and supportive milieu at the CDC Clinic, 2) provision of five structured educational, support and behavioral skills building sessions, and (3) three weekly ART planning sessions.
Read the detailed description
Enhanced Adherence Support (E-ASP)
All patients will receive sessions one and two of the Standard ASP. Following randomization, the intervention (experimental) arm patients receive the E-ASP described below and the standard of care (control) arm patients receive session three of the S-ASP.
Two health educators are employed and trained to administer E-ASP. The goal of the E-ASP is to identify and address patient deficits in information, motivation, and behavioural skills that inhibit consistent and correct self-administration of ARV medications, including those skills required to adhere to the clinic visit schedule. By using specific motivational techniques (Motivational Interviewing) and structured one-on-one sessions, the health educator empower patients to pre-empt situations that have been shown to lead to non-adherence and make plans for situations in which they are less likely to adhere.
Components of the E-ASP
The E-ASP augments S-ASP and consistS of several interconnected components: 1) development and maintenance of an educational and supportive milieu at the CDC Clinic, 2) provision of five structured education, support and behavioural skills building sessions, and (3) three weekly ART planning sessions.
Development and Maintenance of an Educational and Supportive Milieu
A separate room is available for exclusive use of the E-ASP. This room has educational materials available at all times, and is a comfortable area for patients to relax and socialize with one another during the course of their time at the CDC clinic.
Provision by Study Health Educator of 5 Structured Education, Support, and Behavioural Skills Sessions
The educational, support, and behavioural skills building sessions consist of five, one-on-one interactive sessions that will be conducted by the health educator. The sessions take place at five important times during patients' early ART:
- On the day of commencement of ART - "Preparing to take ART medications"
- 2 weeks after starting ART - "Adjusting to taking ART medications"
- 2 months after starting ART - "Feeling good and staying healthy taking ART medications"
- 3 months after starting ART - "Planning for ongoing HIV care and daily ART medications"
- 6 months after starting ART - "Preparation for lifelong HIV care and daily ART medications"
The content matter (key educational, support and skills points/messages) for the sessions is conveyed by the study health educator using specially designed story board flip charts, put into table-standing easel display books; the front side faces the patient and the backside faces the health educator. Posters including all pertinent images and messages will be put onto the walls for ease of summarizing the information, and for providing an overview of important messages. All messages will also be conveyed in pictorial form to ensure that literacy levels of the cohort do not negatively affect understanding.
The other important educational, motivation and skills building tool available is a double-sided Adherence Problem Solving Pocket Card. This tool lists commonly occurring medication adherence problems on the front side and practical solutions/strategies on the back.
- Conditions
- HIV Infections
- Being tested
- Enhanced adherence support, Standard adherence support
- Keywords
- adherence, treatment, antiretroviral, HAART, HIV, Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced adherence supportBehavioural
The enhanced adherence support intervention consists of 5 one-on-one, Information-Motivation-Behavioral Skills (IMB) theory-based counseling sessions, as well as a problem-solving card which summarizes key messages and strategies. The counseling sessions are given at key points post-initiation of therapy: at baseline, 2 weeks, 2 months, 3 months, and 6 months. Three brief weekly ART planning sessions are conducted post-initiation of therapy.
Standard adherence supportBehavioural
The control arm receives the standard of care adherence support which consists of three group counseling adherence sessions conducted prior to initiation of therapy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | enhanced adherence support for patients initiating antiretroviral therapy Receives: Behavioral: Enhanced adherence support |
| 2 | Active comparator | standard adherence support Receives: Behavioral: Standard adherence support |
What is being measured
The primary outcome is the main question the study is designed to answer.
suppressed viral load at 9 months
Those participants with suppressed viral load at 9 months will be classed as treatment success, all others will be classed as treatment failures for the purposes of this outcome.
Measured: 9 months
Secondary outcomes (8)
feasibility of E-ASP in this resource constrained setting
Measured: one year
Secondly to describe the relationship between adherence and viral load and CD4+counts
Measured: 2 months, 9 months and 12 months
describe factors associated with poor/good adherence in this group
Measured: one year
describe the relationship between early adherence and adherence at subsequent timepoints
Measured: 2 weeks, and 2 and 9 months after start ART and 12 months
to establish the validity of self-reported adherence (in relation to pill counts) in this context
Measured: one year
to assess the long-term impact of E-ASP on adherence
Measured: 18 months
suppressed viral load at 12 months
Those participants with suppressed viral load will be classed at treatment successes, all others will be classed as treatment failures for this secondary outcome measure.
Measured: 12 months
adherence at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2006 (estimated)
- Study startAug 2007
- Primary completionMar 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for the AIDS Programme of Research in South Africa
- Sponsor type
- Research network
- Collaborators
- Doris Duke Charitable Foundation
- Responsible party
- Principal investigator, Dr Salim S Abdool Karim, Centre for the AIDS Programme of Research in South Africa
- Investigators
- Francois van Loggerenberg, MA(ResPsych), Principal investigator, CAPRISA, University of KwaZulu-Natal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408642
- Sponsor's protocol ID
- CAP 058
- Acronym
- eASP
- Status last verified
- Jan 2016
- First submitted
- 6 Dec 2006
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Amico KR, Toro-Alfonso J, Fisher JD. An empirical test of the information, motivation and behavioral skills model of antiretroviral therapy adherence. AIDS Care. 2005 Aug;17(6):661-73. doi: 10.1080/09540120500038058.
PubMed 16036253van Loggerenberg F, Grant AD, Naidoo K, Murrman M, Gengiah S, Gengiah TN, Fielding K, Abdool Karim SS. Individualised motivational counselling to enhance adherence to antiretroviral therapy is not superior to didactic counselling in South African patients: findings of the CAPRISA 058 randomised controlled trial. AIDS Behav. 2015 Jan;19(1):145-56. doi: 10.1007/s10461-014-0763-6.
PubMed 24696226
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Enhanced Adherence Support Programme for HAART
- ClinicalTrials.gov ID
- NCT00408642
- Acronym / sponsor ID
- eASP / CAP 058
- Conditions
- HIV Infections
- Keywords
- adherence, treatment, antiretroviral, HAART, HIV, Treatment Naive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Centre for the AIDS Programme of Research in South AfricaResearch network
- Collaborators
- Doris Duke Charitable Foundation
- Study start
- Aug 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 7 Dec 2006 (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.
In southern Africa, TB is the most common first AIDS-defining condition. Initiating Antiretroviral therapy (ART) in HIV positive TB patients will lead to the inclusion of the majority of HIV/AIDS patients currently fulfilling the criteria for therapy. Establishing an effective intervention to increase treatment adherence in this group is essential for the successful roll out of ART in the region. This proposed randomized controlled study aims to compare the effectiveness of two adherence support programmes (ASP) for use in patients with HIV-related TB in the context of CAPRISA AIDS Treatment (CAT)programme in KwaZulu-Natal, South Africa; the enhanced adherence support programme (E-ASP) or the standard adherence support programme (S-ASP).
S-ASP consists of three counselor presented, group education sessions. E-ASP is an extension of S-ASP and is based on the Information-Motivation-Behavioral Skills (IMB) Model of Adherence to Antiretroviral Therapy, a theoretical model initially developed to reduce HIV risk behavior. The E-ASP will consist of several interconnected components: 1) development and maintenance of an educational and supportive milieu at the CDC Clinic, 2) provision of five structured educational, support and behavioral skills building sessions, and (3) three weekly ART planning sessions.
Detailed description
Enhanced Adherence Support (E-ASP)
All patients will receive sessions one and two of the Standard ASP. Following randomization, the intervention (experimental) arm patients receive the E-ASP described below and the standard of care (control) arm patients receive session three of the S-ASP.
Two health educators are employed and trained to administer E-ASP. The goal of the E-ASP is to identify and address patient deficits in information, motivation, and behavioural skills that inhibit consistent and correct self-administration of ARV medications, including those skills required to adhere to the clinic visit schedule. By using specific motivational techniques (Motivational Interviewing) and structured one-on-one sessions, the health educator empower patients to pre-empt situations that have been shown to lead to non-adherence and make plans for situations in which they are less likely to adhere.
Components of the E-ASP
The E-ASP augments S-ASP and consistS of several interconnected components: 1) development and maintenance of an educational and supportive milieu at the CDC Clinic, 2) provision of five structured education, support and behavioural skills building sessions, and (3) three weekly ART planning sessions.
Development and Maintenance of an Educational and Supportive Milieu
A separate room is available for exclusive use of the E-ASP. This room has educational materials available at all times, and is a comfortable area for patients to relax and socialize with one another during the course of their time at the CDC clinic.
Provision by Study Health Educator of 5 Structured Education, Support, and Behavioural Skills Sessions
The educational, support, and behavioural skills building sessions consist of five, one-on-one interactive sessions that will be conducted by the health educator. The sessions take place at five important times during patients' early ART:
- On the day of commencement of ART - "Preparing to take ART medications"
- 2 weeks after starting ART - "Adjusting to taking ART medications"
- 2 months after starting ART - "Feeling good and staying healthy taking ART medications"
- 3 months after starting ART - "Planning for ongoing HIV care and daily ART medications"
- 6 months after starting ART - "Preparation for lifelong HIV care and daily ART medications"
The content matter (key educational, support and skills points/messages) for the sessions is conveyed by the study health educator using specially designed story board flip charts, put into table-standing easel display books; the front side faces the patient and the backside faces the health educator. Posters including all pertinent images and messages will be put onto the walls for ease of summarizing the information, and for providing an overview of important messages. All messages will also be conveyed in pictorial form to ensure that literacy levels of the cohort do not negatively affect understanding.
The other important educational, motivation and skills building tool available is a double-sided Adherence Problem Solving Pocket Card. This tool lists commonly occurring medication adherence problems on the front side and practical solutions/strategies on the back.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Enhanced adherence supportenhanced adherence support for patients initiating antiretroviral therapy |
| 2 | Active comparator | Behavioral: Standard adherence supportstandard adherence support |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients enrolled in the CAPRISA CAT programme and the CDC.
- Willing and able to provide written consent to take part in the study.
- > 18 years of age (to give consent for participation)
- Eligible for initiation of HAART (currently CD4+ <200)
Key exclusion criteria (1 listed)
- Unwillingness or inability to adhere to the study schedule
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 |
|---|---|---|
| Enhanced adherence supportThe enhanced adherence support intervention consists of 5 one-on-one, Information-Motivation-Behavioral Skills (IMB) theory-based counseling sessions, as well as a problem-solving card which summarizes key messages and strategies. The counseling sessions are given at key points post-initiation of therapy: at baseline, 2 weeks, 2 months, 3 months, and 6 months. Three brief weekly ART planning sessions are conducted post-initiation of therapy. | Behavioural | 1 |
| Standard adherence supportThe control arm receives the standard of care adherence support which consists of three group counseling adherence sessions conducted prior to initiation of therapy. | Behavioural | 2 |
Primary outcome
suppressed viral load at 9 months
Time frame: 9 months
Those participants with suppressed viral load at 9 months will be classed as treatment success, all others will be classed as treatment failures for the purposes of this outcome.
8 secondary outcomes
feasibility of E-ASP in this resource constrained setting
Time frame: one year
Secondly to describe the relationship between adherence and viral load and CD4+counts
Time frame: 2 months, 9 months and 12 months
describe factors associated with poor/good adherence in this group
Time frame: one year
describe the relationship between early adherence and adherence at subsequent timepoints
Time frame: 2 weeks, and 2 and 9 months after start ART and 12 months
to establish the validity of self-reported adherence (in relation to pill counts) in this context
Time frame: one year
to assess the long-term impact of E-ASP on adherence
Time frame: 18 months
suppressed viral load at 12 months
Time frame: 12 months
adherence at 6 months
Time frame: 6 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 1 Feb 2016.
- Background: PubMed 16036253Amico KR, Toro-Alfonso J, Fisher JD. An empirical test of the information, motivation and behavioral skills model of antiretroviral therapy adherence. AIDS Care. 2005 Aug;17(6):661-73. doi: 10.1080/09540120500038058.
- Results publication: PubMed 24696226van Loggerenberg F, Grant AD, Naidoo K, Murrman M, Gengiah S, Gengiah TN, Fielding K, Abdool Karim SS. Individualised motivational counselling to enhance adherence to antiretroviral therapy is not superior to didactic counselling in South African patients: findings of the CAPRISA 058 randomised controlled trial. AIDS Behav. 2015 Jan;19(1):145-56. doi: 10.1007/s10461-014-0763-6.
- Primary outcome paperLink provided by the sponsor.
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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.
Francois van Loggerenberg, MA(ResPsych) principal investigator
CAPRISA, University of KwaZulu-Natal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enhanced adherence support and Standard adherence support in people with HIV Infections, run by Centre for the AIDS Programme of Research in South Africa at 1 site in South Africa.
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 4 inclusion and 1 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 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
suppressed viral load at 9 months (time frame: 9 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 NCT00408642, which also lists 2 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 1 Feb 2016.