NCT02419066

Brief Summary

Determine the level, patterns, and correlates of objectively measured ART adherence in early and advanced-stage disease, among pregnant and non-pregnant individuals, to determine the need and nature of interventions to support early ART adherence in Uganda and South Africa

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
904

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

2.7 years

First QC Date

April 6, 2015

Last Update Submit

August 14, 2018

Conditions

Medication AdherenceHIV

Outcome Measures

Primary Outcomes (1)

  • HIV Adherence

    ART adherence will be monitored continuously, up to 12 months, using the Wisepill device.

    12 months

Secondary Outcomes (2)

  • HIV RNA viral load

    12 months

  • Retention in HIV care

    Attendance at scheduled visit (w/in 45 days)

Study Arms (3)

men and women with CD4 >=350

electronic monitoring of ARV adherence in men and women with CD4 \>=350

pregnant women with CD4 >=350

electronic monitoring of ARV adherence in pregnant women with CD4 \>=350

men and women with CD4 <200

electronic monitoring of ARV adherence in men and women with CD4 \<200

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study participants will be HIV-infected adults initiating antiretroviral therapy at recruitment sites in southwestern Uganda (Mbarara, Kabwohe) and Cape Town (Gugulethu) South Africa. They will have either early (CD4 \>350) or late (CD4 \<200) HIV infection.

You may qualify if:

  • Participants will be ART naïve and initiating within one month of enrollment date
  • Participants will be at least 18 years of age
  • Participants will be able to provide informed consent
  • Participants will live within 60 km of the clinic; intention to stay in the area for the next year
  • Participants will either be 1) in early-stage disease (CD4\>350) with WHO stage I (i.e., asymptomatic), or 2) in advanced-stage disease (CD4\<200).
  • Pregnant participants will be 34 weeks or less in pregnancy (per best available estimates

You may not qualify if:

  • Live \>60 km from the clinic (due to logistics of following participants) or intention to move outside 60km area within the next year
  • \<18 years old (adherence patterns and determinants likely differ significantly from those \>18 years)
  • Currently in an intermediate stages of disease (i.e., CD4 200-349; the intent of the proposed research is to examine differences in adherence between HIV-infected people initiating ART at early versus advanced-staged disease)
  • Women who have a CD4\<200 and who report current pregnancy at the time of consent
  • Unable to provide informed consent (e.g., due to mental limitations or intoxication)
  • Anyone who does not initiate on ART within 1 month of the enrollment date
  • Any pregnant participant greater than 34 weeks in pregnancy (per best available estimate)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hannan Crusaid Treatment Centre (HCTC), Gugulethu

Cape Town, Western Cape, 7760, South Africa

Location

Immune Suppression Syndrome (ISS) Clinic

Mbarara, Mbarara District, Uganda

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma, dried blood spots

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Jessica Haberer, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Jessica Haberer, MD, MS

Study Record Dates

First Submitted

April 6, 2015

First Posted

April 17, 2015

Study Start

February 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

August 16, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

De-identified data will be available at the end of the study upon request.

Locations

ZA(1)UG(1)