NCT03789448

Brief Summary

The purpose of this study is to evaluate the impact of offering early antiretroviral therapy to HIV-positive individuals in government-managed health facilities in Swaziland on a range of economic outcomes

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,019

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

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

September 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 28, 2018

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

December 16, 2018

Last Update Submit

January 3, 2019

Conditions

HIV/AIDS

Keywords

Antiretroviral Treatment

Outcome Measures

Primary Outcomes (2)

  • Total healthcare expenditures (for hospitalization and primary care)

    Including direct health care costs (e.g., surgery, medication, consultation) and indirect costs (e.g., transport to clinic, payment for someone to look after children, salary lost for time off...)

    12 months

  • Total productivity hours

    Total Hours per day spent on income generation activities

    24 hours

Secondary Outcomes (3)

  • Rate of participants with current employment

    At study completion, an average of 1.5 years

  • Total sum of self-reported monthly expenditures of the participant's household

    12 months

  • Household Assets Ownership and Living Standards Index

    At study completion, an average of 1.5 years

Study Arms (2)

National HIV Treatment Guidelines

NO INTERVENTION

HIV-positive individuals are offered ART per Swaziland's national treatment guidelines

Early Access to ART for All

EXPERIMENTAL

HIV-positive individuals who are aged 18 years or older are initiated on ART regardless of client's immunological and clinical staging (excluding pregnant or breastfeeding women)

Other: Early Access to ART for All

Interventions

Early Access to ART for AllOTHER

All HIV-positive individuals will be initiated on Swaziland's recommended first-line ART regimen, unless contraindicated when recommended alternate regimens will be used per national guidelines

Early Access to ART for All

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All HIV-positive individuals who are aged 18 years or older, are ART naïve and attend the health facilities included in the study

You may not qualify if:

  • All HIV-positive individuals who are \<18 years of age
  • All HIV-positive pregnant or breastfeeding women
  • All HIV-positive individuals who did not consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Briggs J, Teyssier N, Nankabirwa JI, Rek J, Jagannathan P, Arinaitwe E, Bousema T, Drakeley C, Murray M, Crawford E, Hathaway N, Staedke SG, Smith D, Rosenthal PJ, Kamya M, Dorsey G, Rodriguez-Barraquer I, Greenhouse B. Sex-based differences in clearance of chronic Plasmodium falciparum infection. Elife. 2020 Oct 27;9:e59872. doi: 10.7554/eLife.59872.

    PMID: 33107430DERIVED

  • Mobegi FM, Leong LE, Thompson F, Taylor SM, Harriss LR, Choo JM, Taylor SL, Wesselingh SL, McDermott R, Ivey KL, Rogers GB. Intestinal microbiology shapes population health impacts of diet and lifestyle risk exposures in Torres Strait Islander communities. Elife. 2020 Oct 19;9:e58407. doi: 10.7554/eLife.58407.

    PMID: 33074097DERIVED

  • Steinert JI, Khan S, Mlambo K, Walsh FJ, Mafara E, Lejeune C, Wong C, Hettema A, Ogbuoji O, Vollmer S, De Neve JW, Mazibuko S, Okello V, Barnighausen T, Geldsetzer P. A stepped-wedge randomised trial on the impact of early ART initiation on HIV-patients' economic outcomes in Eswatini. Elife. 2020 Aug 24;9:e58487. doi: 10.7554/eLife.58487.

    PMID: 32831169DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Proto-Oncogene Proteins c-raf

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

raf KinasesMAP Kinase Kinase KinasesProtein Serine-Threonine KinasesProtein KinasesPhosphotransferases (Alcohol Group Acceptor)PhosphotransferasesTransferasesEnzymesEnzymes and CoenzymesIntracellular Signaling Peptides and ProteinsProteinsAmino Acids, Peptides, and ProteinsProto-Oncogene ProteinsOncogene ProteinsNeoplasm Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
University Hospital Heidelberg

Study Record Dates

First Submitted

December 16, 2018

First Posted

December 28, 2018

Study Start

September 1, 2014

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

January 4, 2019

Record last verified: 2019-01