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TerminatedNCT03371914Updated Aug 5, 2020

Costs, Efficiency and the Role of Management in HIV Prevention Interventions for Female Sex Workers in Nigeria

An interventional study of Management training and data feedback in HIV/AIDS, sponsored by Instituto Nacional de Salud Publica, Mexico. Terminated at 1 site in Nigeria. Per ClinicalTrials.gov, last updated 2020-08-05.

Sponsored by Instituto Nacional de Salud Publica, Mexico · Not applicable, Interventional, and Health services research

Why this study was terminated
Due to defunding of USAID project that supported the majority of the sites selected in the randomization.

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Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 25 studies in Acquired Immunodeficiency Syndrome with a site in Nigeria — 3 open to participants now, 4 under way, 1 of them phase 3. Acquired Immunodeficiency Syndrome · Nigeria.

Enrollment
21st of 22
32 · median 466
Started
2017
with 3 others
No phase
15 of 25
2 open now
Registered
11th of 25
by date
Lead sponsor
1 of 25
Instituto Nacional de Salud Publica, Mexico

Among the 25 studies in Acquired Immunodeficiency Syndrome with a site in Nigeria, this one is the 21st largest by enrollment of the 22 interventional ones that give a count, is one of 4 that started in 2017, is one of 15 with no phase, and was the 11th registered.

Acquired Immunodeficiency Syndrome

3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.

Browse Acquired Immunodeficiency Syndrome studies →

Open to participants now

3 of the 25 studies in Acquired Immunodeficiency Syndrome with a site in Nigeria are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Nigeria have not opened yet or have stopped. Only those recruiting at a site in Nigeria →

Who these studies take

Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.

This study: all sexes · healthy volunteers too.

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02

Study 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.

03

Conditions studied

  • HIV/AIDS

Keywords

  • costing
  • behavioral intervention
  • management
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Treatment: Management + data training

    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

  • No intervention
    Control: data training only

    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

  • BehavioralManagement training and data feedback

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Two years

  2. 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.

    Time frame: Two years

  3. 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.

    Time frame: Two years

  4. 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.

    Time frame: Two years

Secondary outcomes

  1. Productivity of HIV education

    Productivity of the organizations will be measured as the number of outputs produced for the HIV education intervention-number of FSW reached by HIV education.

    Time frame: Two years

  2. Productivity of HIV testing

    Productivity of the organizations will be measured as the number of outputs produced for the HIV testing and counseling interventions-number of FSW tested for HIV.

    Time frame: Two years

  3. Productivity of STI treatment

    Productivity of the organizations will be measured as the number of outputs produced for the STI treatment intervention-number of FSW treated for STIs.

    Time frame: Two years

  4. Job satisfaction

    Measured through a composite score of five Likert scale questions about satisfaction, answers ranging from 1-5, 1 being "very dissatisfied" and 5 being "very satisfied".

    Time frame: Two years

07

Study locations

1 site
  • Society for Family Health, Headquarters
    Abuja, Nigeria
08

References and documents

Publications

  • 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. PubMed 30386184 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2017 to primary completion in Sep 2018, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2017
First posted
Dec 13, 2017
StartActual
Aug 12, 2017
Primary completionActual
Sep 1, 2018
CompletionActual
Dec 1, 2019
Last update
Aug 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03371914
Lead sponsor
Instituto Nacional de Salud Publica, Mexico
Collaborators
Society For Family Health (SFH), National Agency for the Control of AIDS (NACA)
Responsible party
Sergio Bautista Arredondo (Director of Health Economics, Instituto Nacional de Salud Publica, Mexico) — Principal investigator
First posted
Dec 13, 2017
Start date
Aug 12, 2017
Primary completion
Sep 1, 2018
Completion
Dec 1, 2019
Last update
Aug 5, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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