NCT02627365

Brief Summary

The study aims to develop and evaluate the efficacy and causal mechanisms of an interactive SMS intervention to optimize individual health and secondary HIV prevention benefits of ART in HIV-positive FSWs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 8, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

2.6 years

First QC Date

December 8, 2015

Last Update Submit

November 2, 2020

Conditions

HIV/AIDS

Keywords

ARTmobile messagingbehaviourmotivation

Outcome Measures

Primary Outcomes (1)

  • Plasma HIV-1 viral load

    The plasma HIV-1 viral load will be compared between participants in the intervention and in the non-intervention arm.

    six months

Study Arms (2)

Individualized, interactive SMS

EXPERIMENTAL

Individualized, interactive SMS intervention plus Standard care. Messages sent automatically using the Text-IT system.

Behavioral: Individualized, interactive short messaging intervention

Standard care

NO INTERVENTION

Standard care according to Kenyan guidelines, including clinic-based adherence education and counseling.

Interventions

Individualized, interactive short messaging interventionBEHAVIORAL

An Individualized, interactive short messaging intervention reminding study participants to take antiretroviral medication and report any problems.

Individualized, interactive SMS

Eligibility Criteria

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

You may qualify if:

  • More than 18 years or emancipated minor
  • Has access to mobile phone
  • Self-identifying female sex worker
  • Willing to receive study SMS messages
  • HIV-positive (any WHO stage or CD4)
  • Able to read or have someone else read
  • ART naïve
  • Informed consent obtained and signed.

You may not qualify if:

  • Plans to move away in next 6 months
  • Contraindication to ART

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Health Project, Mombasa

Mombasa, 254, Kenya

Location

Related Publications (2)

  • Aunon FM, Wanje G, Richardson BA, Masese L, Odeny TA, Kinuthia J, Mandaliya K, Jaoko W, Simoni JM, McClelland RS. Randomized controlled trial of a theory-informed mHealth intervention to support ART adherence and viral suppression among women with HIV in Mombasa, Kenya: preliminary efficacy and participant-level feasibility and acceptability. BMC Public Health. 2023 May 8;23(1):837. doi: 10.1186/s12889-023-15638-3.

    PMID: 37158872DERIVED

  • Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.

    PMID: 32779730DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeBehavior

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

Study Officials

  • R. Scott McClelland, M.D, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Medicine, Epidemiology, and Global Health

Study Record Dates

First Submitted

December 8, 2015

First Posted

December 10, 2015

Study Start

January 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

November 3, 2020

Record last verified: 2020-11

Locations

KE(1)