- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04160169
Counseling on Injectable Contraception and HIV Risk in Tanzania
8. november 2019 opdateret af: University of North Carolina, Chapel Hill
Counseling on Injectable Contraception and HIV Risk: Evaluation of a Pilot Intervention in Tanzania
The main objective of the evaluation was to assess the effect of providing injectable and HIV risk counseling messages on contraceptive knowledge and behavior during a three month pilot intervention in ten healthcare facilities in Tanzania.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The evaluation assessed the effect of providing injectable and HIV risk counseling messages on contraceptive knowledge and uptake during a three month pilot intervention.
The intervention was conducted September-November 2018 in ten healthcare facilities located in the Iringa and Njombe regions of Tanzania.
Data collection for the evaluation occurred November-December 2018 and included 471 client exit interviews, 26 healthcare provider interviews, and the extraction of monthly aggregate service statistics for 12 months prior to the intervention and three months of the intervention.
Univariate and bivariate analyses were used to assess quantitative interview data.
Thematic qualitative assessment was used to assess qualitative interview data from healthcare providers.
Interrupted time series analysis was used to assess changes in the trend of monthly contraceptive uptake.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
10
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Iringa, Tanzania
- Ihongole Health Center
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Iringa, Tanzania
- Ipogolo Health Center
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Iringa, Tanzania
- Kimande Health Center
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Njombe, Tanzania
- Ipelele Health Center
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Njombe, Tanzania
- Kibena Regional Referral Hospital
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Njombe, Tanzania
- Makambako Hospital
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Njombe, Tanzania
- Makete Hospital
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Njombe, Tanzania
- Njombe Health Center
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Iringa
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Ilula, Iringa, Tanzania
- Ilula Hospital
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Mafinga, Iringa, Tanzania
- Mafinga Hospital
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
15 år til 49 år (Barn, Voksen)
Tager imod sunde frivillige
N/A
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
All women attending a participating healthcare facility during the three month intervention period and who met eligibility criteria received the hormonal contraception and HIV risk messages.
Beskrivelse
Inclusion Criteria:
- Expressed interest in injectable use
- HIV-negative or unknown HIV status
Exclusion Criteria:
- Positive HIV status known to healthcare provider
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of clients obtaining an injectable during their family planning appointment
Tidsramme: After implementation of counseling messages, up to 13 weeks
|
Injectable uptake of interviewed clients
|
After implementation of counseling messages, up to 13 weeks
|
|
Percent of clients obtaining an injectable during their family planning appointment
Tidsramme: After implementation of counseling messages, up to 13 weeks
|
Injectable uptake of interviewed clients
|
After implementation of counseling messages, up to 13 weeks
|
|
Monthly total number of family planning clients by method obtained
Tidsramme: September 2017 through November 2018
|
Contraceptive uptake during pilot intervention
|
September 2017 through November 2018
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of correct hormonal contraception and HIV risk counseling messages mentioned during spontaneous recall
Tidsramme: After implementation of counseling messages, up to 13 weeks
|
Knowledge of hormonal contraception and HIV risk messages
|
After implementation of counseling messages, up to 13 weeks
|
|
Percent of correct hormonal contraception and HIV risk counseling messages mentioned during spontaneous recall
Tidsramme: After implementation of counseling messages, up to 13 weeks
|
Knowledge of hormonal contraception and HIV risk messages
|
After implementation of counseling messages, up to 13 weeks
|
|
Number of correct True/False statements on hormonal contraception and HIV (11 total)
Tidsramme: After implementation of counseling messages, up to 13 weeks
|
Knowledge of hormonal contraception and HIV risk messages
|
After implementation of counseling messages, up to 13 weeks
|
|
Percent of correct True/False statements on hormonal contraception and HIV (11 total)
Tidsramme: After implementation of counseling messages, up to 13 weeks
|
Knowledge of hormonal contraception and HIV risk messages
|
After implementation of counseling messages, up to 13 weeks
|
|
Number of interviewed clients reporting an intention to use condoms as a dual method
Tidsramme: After implementation of counseling messages, up to 13 weeks
|
Intention to use condoms as a dual method
|
After implementation of counseling messages, up to 13 weeks
|
|
Percent of interviewed clients reporting an intention to use condoms as a dual method
Tidsramme: After implementation of counseling messages, up to 13 weeks
|
Intention to use condoms as a dual method
|
After implementation of counseling messages, up to 13 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Janine Barden-O'Fallon, PhD, University of North Carolina, Chapel Hill
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. september 2018
Primær færdiggørelse (Faktiske)
30. november 2018
Studieafslutning (Faktiske)
30. november 2018
Datoer for studieregistrering
Først indsendt
7. november 2019
Først indsendt, der opfyldte QC-kriterier
8. november 2019
Først opslået (Faktiske)
12. november 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. november 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. november 2019
Sidst verificeret
1. november 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 18-1049
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Deidentified data from the client interviews are publicly available through MEASURE Evaluation Dataverse in STATA format.
The study report is also available on Dataverse.
IPD-delingstidsramme
Data are currently available and will remain on Dataverse.org
IPD-delingsadgangskriterier
Site registration required.
IPD-deling Understøttende informationstype
- CSR
Studiedata/dokumenter
-
Individuelt deltagerdatasæt
Informations-id: doi:10.15139/S3/XEXQXO
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Counseling messages on injectable use and HIV acquisition risk
-
Yale UniversityNational Institute on Drug Abuse (NIDA)AfsluttetHIV-infektioner | OpiatafhængighedKina, Forenede Stater