NCT03371914

Brief Summary

This study seeks to measure the costs associated with HIV prevention service delivery to female sex workers (FSW) in Nigeria, as well as examine the relationship between management practices at the community-based organizations (CBOs) and costs. To complete these goals, the study will collect both retrospective and prospective data from CBOs and from centralized information from study partners (Society for Family Health, SFH). In the prospective section of the study, CBOs will be sampled and assigned to either treatment or control groups. Data collected at the CBOs will be aggregated by the CBO managers, and those in the treatment group will receive feedback on their performance on a monthly basis. Those in the treatment group will additionally receive a management training to guide their management practices. Researchers hypothesize that there will be improvements in management indicators and therefore decreases in costs at CBOs in the treatment group. Results will be disseminated to local, national, and international stakeholders.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 12, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 16, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

1.1 years

First QC Date

September 16, 2017

Last Update Submit

August 3, 2020

Conditions

Keywords

costingbehavioral interventionmanagement

Outcome Measures

Primary Outcomes (4)

  • Change in cost per female sex worker reached by HIV education services

    This measures the total cost of HIV education provision, divided by the number of female sex workers (FSWs) reached by the service.

    Two years

  • Change in cost per female sex worker tested

    This measures the total cost of HIV testing and counseling, divided by the number of FSWs tested.

    Two years

  • Change in cost per female sex worker treated for STIs (sexually transmitted infections)

    This measures the total cost of STI treatment, divided by the number of FSWs treated for any STI.

    Two years

  • Change in cost per female sex worker tested positive

    This measures the total cost of HIV testing and counseling, divided by the number of FSWs tested positive for HIV.

    Two years

Secondary Outcomes (4)

  • Productivity of HIV education

    Two years

  • Productivity of HIV testing

    Two years

  • Productivity of STI treatment

    Two years

  • Job satisfaction

    Two years

Study Arms (2)

Treatment: Management + data training

EXPERIMENTAL

The treatment group in the study will receive a 5-day training. The first two days of the training will consist of introducing the data collection tools and collecting baseline data. Days three through five of the training will consist of a variety of management topics. On a monthly basis, the treatment group will receive data visualizations that will compare their site's performance that month to pervious performance and to other sites in the study. Both treatment and control groups will collect information regarding input costs and number of services provided on a monthly basis.

Behavioral: Management training and data feedback

Control: data training only

NO INTERVENTION

The control group will receive only a 2-day training which will focus on data collection alone. Both treatment and control groups will collect information regarding input costs and number of services provided on a monthly basis.

Interventions

The management training will consist of a variety of management topics, such as financial, workplace and staff management. The training will include a number of tools that the managers will be expected to bring back with them and use regularly at their site. There will be monthly refresher trainings for the managers via an online platform, where participants will interact about the topics covered in the training and others relevant to their work as managers. Participants will also receive monthly visualizations that compare the data that they enter via tablet monthly to both (1) their baseline data, and (2) to other sites' data. Outcomes that will be measured and reported back to sites include cost per client tested, number of condoms distributed, and number of FSW reached by educational interventions.

Treatment: Management + data training

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clusters: community-based organizations that serve female sex workers under Society for Family Health, through the SHIPs or Global Fund grants
  • Participants: managers ("officers") that oversee the functions of the organization and supervise volunteer staff

You may not qualify if:

  • Clusters: excludes organizations not serving female sex workers and not working under Society for Family Health, through Global Fund or SHIPs grants
  • Participants: excludes anyone not explicitly working as a manager overseeing volunteer implementation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Society for Family Health, Headquarters

Abuja, Nigeria

Location

Related Publications (1)

  • Bautista-Arredondo S, Nance N, Salas-Ortiz A, Akeju D, Oluwayinka AG, Ezirim I, Anenih J, Chima C, Amanze O, Omoregie G, Ogungbemi K, Aliyu SH. The role of management on costs and efficiency in HIV prevention interventions for female sex workers in Nigeria: a cluster-randomized control trial. Cost Eff Resour Alloc. 2018 Oct 23;16:37. doi: 10.1186/s12962-018-0107-x. eCollection 2018.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Health Economics

Study Record Dates

First Submitted

September 16, 2017

First Posted

December 13, 2017

Study Start

August 12, 2017

Primary Completion

September 1, 2018

Study Completion

December 1, 2019

Last Updated

August 5, 2020

Record last verified: 2020-08

Locations