NCT02281578

Brief Summary

The Phase II trial will assess the feasibility, acceptance, safety, pathways, and initial effectiveness of a community-based combination HIV prevention intervention among bar-based female sex workers in Iringa, Tanzania. Results will inform an appropriately powered Phase III RCT as warranted.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
496

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Oct 2015

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

October 29, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 3, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2018

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

2.3 years

First QC Date

October 29, 2014

Last Update Submit

March 11, 2020

Conditions

HIV

Keywords

Sex WorkersPrevention

Outcome Measures

Primary Outcomes (2)

  • HIV incidence

    Biologic assessment of new infections among HIV-uninfected participants via blood draw

    18 months

  • Viral load suppression

    Biological assessment of viral suppression among HIV-infected participants via blood draw

    18 months

Secondary Outcomes (2)

  • Consistent condom use

    18 months

  • Adherence to ART

    18 months

Study Arms (2)

Combination prevention

EXPERIMENTAL

Community-based, combination HIV prevention intervention package

Behavioral: Community-based combination HIV prevention intervention

Standard of care

ACTIVE COMPARATOR

Locally run standard of care HIV prevention, treatment and care services

Behavioral: Standard of care HIV services

Interventions

Community-based combination HIV prevention interventionBEHAVIORAL

The combination package will include integrated biomedical, behavioral and structural components: (1) mobile HIV testing and risk reduction counseling; (2) service navigation to facilitate access to treatment and retention in care; (3) sensitivity training for HIV clinical care providers; (4) SMS text messages to promote adherence to care and ART; (5) venue-based peer education and condom distribution; and (6) a community drop-in-center to promote cohesion and collective action to reduce stigma and discrimination.

Combination prevention
Standard of care HIV servicesBEHAVIORAL

Locally available standard of care HIV prevention, treatment and care services

Standard of care

Eligibility Criteria

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

You may qualify if:

  • years old, female, exchange sex for money in entertainment venue
  • key informants working on HIV among sex workers in the region.

You may not qualify if:

  • Psychiatric/psychological condition impeding informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUHAS

Iringa, Tanzania

Location

Related Publications (3)

  • Kerrigan D, Mbwambo J, Likindikoki S, Davis W, Mantsios A, Beckham SW, Leddy A, Shembilu C, Mwampashi A, Aboud S, Galai N. Project Shikamana: Community Empowerment-Based Combination HIV Prevention Significantly Impacts HIV Incidence and Care Continuum Outcomes Among Female Sex Workers in Iringa, Tanzania. J Acquir Immune Defic Syndr. 2019 Oct 1;82(2):141-148. doi: 10.1097/QAI.0000000000002123.

    PMID: 31513552BACKGROUND

  • Kerrigan D, Mbwambo J, Likindikoki S, Beckham S, Mwampashi A, Shembilu C, Mantsios A, Leddy A, Davis W, Galai N. Project Shikamana: Baseline Findings From a Community Empowerment-Based Combination HIV Prevention Trial Among Female Sex Workers in Iringa, Tanzania. J Acquir Immune Defic Syndr. 2017 Jan 1;74 Suppl 1(Suppl 1):S60-S68. doi: 10.1097/QAI.0000000000001203.

    PMID: 27930613BACKGROUND

  • Beckham SW, Mantsios A, Galai N, Likindikoki S, Mbwambo J, Davis W, Kerrigan D. Acceptability of multiple modalities of pre-exposure prophylaxis (PrEP) among female sex workers in Tanzania: a mixed-methods study. BMJ Open. 2022 Aug 17;12(8):e058611. doi: 10.1136/bmjopen-2021-058611.

    PMID: 35977762DERIVED

Study Officials

  • Deanna L Kerrigan, PhD, MPH

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 29, 2014

First Posted

November 3, 2014

Study Start

October 1, 2015

Primary Completion

January 8, 2018

Study Completion

January 8, 2018

Last Updated

March 13, 2020

Record last verified: 2020-03

Locations

TA(1)