HIV PreventionNCT02702895
Assessment of ASPIRE and HOPE Adherence
An observational study of HIV Prevention, run by Microbicide Trials Network at 7 sites in 4 countries.
Trial summary
MTN-032 is an exploratory sub-study of the ASPIRE and HOPE trials that will utilize qualitative In-Depth Interviews (IDIs) and Focus-Group Discussions (FGDs) to explore socio-contextual and trial specific issues which affected participants' adherence to the dapivirine vaginal ring (VR), as well as male partner… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- In-depth Interview (IDIs) or Focus Group Discussion (FGD)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 302 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 13 Jun 2016to 19 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A sample of 187 former ASPIRE participants was selected to take part in Phase 1 of the study. A sample of up to 156 HOPE participants will be selected for participation in Phase 2. In addition, a sample of up to 120 male partners of HOPE participants who provided consent to have their male partners contacted will be selected for participation in Phase 2. Participants will all be adult women and their adult male partners from seven sites in three African countries: South Africa, Uganda and Malawi. It is anticipated that participants and their male partners will be representative of the overall ASPIRE and HOPE trials by enrolling participants from each of the participating ASPIRE and HOPE countries.
Who may be able to join
- Participated in the ASPIRE protocol, randomized to active product and informed of their randomization assignment.
- Able and willing to provide written informed consent in one of the study languages.
- Able and willing to complete the required study procedures.
- For participants who did not acquire an HIV infection while taking part in ASPIRE, evidence of study product dispensation at a minimum of three consecutive ASPIRE scheduled clinic visits. For participants who acquired an HIV infection while taking part in ASPIRE, evidence of study product dispensation in the month prior to the participant's acquisition of HIV infection.
- For participants who did not acquire an HIV infection while taking part in ASPIRE, have a minimum of three ASPIRE PK data measurement points available. For participants who acquired HIV infection while taking part in ASPIRE, have a minimum of one ASPIRE PK data measurement available.
- Participated in the HOPE protocol.
Show all 16Show fewer
- Able and willing to provide written informed consent in one of the study languages.
- Able and willing to complete the required study procedures.
- For participants who did not acquire an HIV infection while taking part in HOPE, evidence of study product dispensation for a minimum of three consecutive months.
- For participants who acquired an HIV infection while taking part in HOPE, evidence of study product dispensation in the month prior to the participant's acquisition of an HIV infection.
- Inclusion Criteria (Phase 2 - Male partners of HOPE participants):
- Identifies as a male sexual partner of a HOPE participant for whom the HOPE participant has given permission to contact.
- Was a male sexual partner of a HOPE participant during her participation in HOPE (regardless of whether she used the ring or not).
- Able and willing to provide written informed consent in one of the study languages.
- Able and willing to complete the required study procedures.
- Is above the age of 18 at the time of study participation.
Who cannot join
- 1. Has any significant medical condition or other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
South Africa3 sites
Botha's Hill Clinical Research Site
Durban, KwaZulu-Natal
CAPRISA eThekwini Clinical Research Site
Durban, KwaZulu-Natal
Wits Reproductive Health and HIV Institute Clinical Research Site
Johannesburg
Zimbabwe2 sites
Spilhaus Clinical Research Site
Harare
Zengeza Clinical Research Site
Harare
Uganda1 site
Makerere University - Johns Hopkins University Research Collaboration Clinical Research Site
Kampala
About this study
MTN-032 is an exploratory sub-study of the ASPIRE and HOPE trials that will utilize qualitative In-Depth Interviews (IDIs) and Focus-Group Discussions (FGDs) to explore socio-contextual and trial specific issues which affected participants' adherence to the dapivirine vaginal ring (VR), as well as male partner attitudes towards and experiences with the dapivirine VR and their perspective of their female partner's attitudes and experiences.
Read the detailed description
The MTN-032 trial is a two-phase exploratory sub-study of the ASPIRE and HOPE trials. A total of 187 former ASPIRE participants aged 19-48 years were enrolled in Phase 1 of this study. Up to 156 HOPE participants and up to 120 male partners of HOPE participants will be selected for participation in Phase 2 of this study. There were approximately 4-6 months allotted for recruitment and follow-up at each site for Phase 1, and 9-12 months allotted for recruitment and follow-up at each site for Phase 2..
MTN-032, an observational study, using interviews and focus group discussions, is primarily designed to identify factors that may have affected participant adherence to study product in ASPIRE and HOPE, including male partner attitudes. MTN-032 will also elicit perceptions about various participant engagement and adherence promotion interventions implemented in ASPIRE and may also explore the potential use of incentives to promote adherence to VR use.
MTN-032 will use study product adherence results from ASPIRE and HOPE, qualitative in-depth interviews (IDI) and focus group discussions (FGD) to explore study product adherence behaviors and strategies used to overcome adherence challenges. An in-depth understanding of the various socio-behavioral factors that contribute to product use adherence may assist in the interpretation of past and ongoing study results and inform implementation of future studies.
- Conditions
- HIV Prevention
- Being tested
- In-depth Interview (IDIs) or Focus Group Discussion (FGD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-depth Interview (IDIs) or Focus Group Discussion (FGD)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Former ASPIRE participants Receives: Behavioral: In-depth Interview (IDIs) or Focus Group Discussion (FGD) | |
| Phase 2 HOPE participants | Former HOPE participants Receives: Behavioral: In-depth Interview (IDIs) or Focus Group Discussion (FGD) | |
| Phase 2 Male Partners | Male partners of HOPE participants Receives: Behavioral: In-depth Interview (IDIs) or Focus Group Discussion (FGD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors affecting product use adherence
Socio-contextual and trial specific issues which affected participants' adherence to the dapivirine VR will be captured by IDI and/or FGD.
Measured: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
Male partner attitudes affecting product use adherence
male partner attitudes towards and experiences with the dapivirine VR, and their perspective of their female partner's attitudes and experienceswill be captured by FGD and/or IDI.
Measured: Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
Secondary outcomes (4)
Perceptions of HIV risk
HIV risk and perceptions of HIV risk in general and specific to participants' and their male partners' motivation to participate in the ASPIRE and/or HOPE trial(s), to use study product (or not) during their participation in ASPIRE and/or HOPE, and male partner support (or lack thereof) of participants' product use in HOPE will be captured by IDI and/or FGD.
Measured: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
Product use patterns
Factors influencing product initiation and patterns of use during ASPIRE and/or HOPE will be captured by IDI and/or FGD.
Measured: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
Perceptions of various adherence support interventions
Participants' perceptions of various adherence support interventions and engagement activities implemented (or not implemented) during ASPIRE and/or HOPE will be captured by IDI and/or FGD.
Measured: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
Understanding of ASPIRE results and ring efficacy
Participants' and their male partners' understanding of the ASPIRE results and ring efficacy, and the impact of this understanding on participants' intention and/or ability to join HOPE and continue in follow-up, on their adherence to the dapivirine VR as part of an open label extension trial as compared to adherence in a Phase 3 safety and effectiveness trial, and male partner support (or lack thereof) of participants' trial participation and product use in HOPE will be captured by IDI and/or FGD.
Measured: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study start13 Jun 2016
- Primary completion19 Dec 2018
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microbicide Trials Network
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Montgomery, PhD, MHS, Study chair, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702895
- Sponsor's protocol ID
- MTN-032
- Other IDs
- UM1AI068633, UM1AI068615, UM1AI106707, Protocol ID#12058
- Status last verified
- Jun 2021
- First submitted
- 31 Aug 2015
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Montgomery ET, Stadler J, Naidoo S, Katz AWK, Laborde N, Garcia M, Reddy K, Mansoor LE, Etima J, Zimba C, Chitukuta M, Soto-Torres L. Reasons for nonadherence to the dapivirine vaginal ring: narrative explanations of objective drug-level results. AIDS. 2018 Jul 17;32(11):1517-1525. doi: 10.1097/QAD.0000000000001868.
PubMed 29957723Naidoo K, Mansoor LE, Katz AWK, Garcia M, Kemigisha D, Morar NS, Zimba CC, Chitukuta M, Reddy K, Soto-Torres L, Naidoo S, Montgomery ET. Qualitative Perceptions of Dapivirine VR Adherence and Drug Level Feedback Following an Open-Label Extension Trial. J Acquir Immune Defic Syndr. 2021 Apr 1;86(4):e90-e96. doi: 10.1097/QAI.0000000000002590.
PubMed 33278181Montgomery ET, Katz AWK, Duby Z, Mansoor LE, Morar NS, Naidoo K, Tsidya M, Chitukuta M, Guma V, Tenza S, Leslie J, Garcia M, Naidoo S. Men's Sexual Experiences with the Dapivirine Vaginal Ring in Malawi, South Africa, Uganda and Zimbabwe. AIDS Behav. 2021 Jun;25(6):1890-1900. doi: 10.1007/s10461-020-03119-2. Epub 2021 Jan 2.
PubMed 33389318
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of ASPIRE and HOPE Adherence
- ClinicalTrials.gov ID
- NCT02702895
- Acronym / sponsor ID
- MTN-032
- Conditions
- HIV Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Microbicide Trials NetworkResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Study start
- 13 Jun 2016 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MTN-032 is an exploratory sub-study of the ASPIRE and HOPE trials that will utilize qualitative In-Depth Interviews (IDIs) and Focus-Group Discussions (FGDs) to explore socio-contextual and trial specific issues which affected participants' adherence to the dapivirine vaginal ring (VR), as well as male partner attitudes towards and experiences with the dapivirine VR and their perspective of their female partner's attitudes and experiences.
Detailed description
The MTN-032 trial is a two-phase exploratory sub-study of the ASPIRE and HOPE trials. A total of 187 former ASPIRE participants aged 19-48 years were enrolled in Phase 1 of this study. Up to 156 HOPE participants and up to 120 male partners of HOPE participants will be selected for participation in Phase 2 of this study. There were approximately 4-6 months allotted for recruitment and follow-up at each site for Phase 1, and 9-12 months allotted for recruitment and follow-up at each site for Phase 2..
MTN-032, an observational study, using interviews and focus group discussions, is primarily designed to identify factors that may have affected participant adherence to study product in ASPIRE and HOPE, including male partner attitudes. MTN-032 will also elicit perceptions about various participant engagement and adherence promotion interventions implemented in ASPIRE and may also explore the potential use of incentives to promote adherence to VR use.
MTN-032 will use study product adherence results from ASPIRE and HOPE, qualitative in-depth interviews (IDI) and focus group discussions (FGD) to explore study product adherence behaviors and strategies used to overcome adherence challenges. An in-depth understanding of the various socio-behavioral factors that contribute to product use adherence may assist in the interpretation of past and ongoing study results and inform implementation of future studies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | – | Behavioral: In-depth Interview (IDIs) or Focus Group Discussion (FGD)Former ASPIRE participants |
| Phase 2 HOPE participants | – | Behavioral: In-depth Interview (IDIs) or Focus Group Discussion (FGD)Former HOPE participants |
| Phase 2 Male Partners | – | Behavioral: In-depth Interview (IDIs) or Focus Group Discussion (FGD)Male partners of HOPE participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A sample of 187 former ASPIRE participants was selected to take part in Phase 1 of the study. A sample of up to 156 HOPE participants will be selected for participation in Phase 2. In addition, a sample of up to 120 male partners of HOPE participants who provided consent to have their male partners contacted will be selected for participation in Phase 2. Participants will all be adult women and their adult male partners from seven sites in three African countries: South Africa, Uganda and Malawi. It is anticipated that participants and their male partners will be representative of the overall ASPIRE and HOPE trials by enrolling participants from each of the participating ASPIRE and HOPE countries.
Key inclusion criteria (16 listed)
- Participated in the ASPIRE protocol, randomized to active product and informed of their randomization assignment.
- Able and willing to provide written informed consent in one of the study languages.
- Able and willing to complete the required study procedures.
- For participants who did not acquire an HIV infection while taking part in ASPIRE, evidence of study product dispensation at a minimum of three consecutive ASPIRE scheduled clinic visits. For participants who acquired an HIV infection while taking part in ASPIRE, evidence of study product dispensation in the month prior to the participant's acquisition of HIV infection.
- For participants who did not acquire an HIV infection while taking part in ASPIRE, have a minimum of three ASPIRE PK data measurement points available. For participants who acquired HIV infection while taking part in ASPIRE, have a minimum of one ASPIRE PK data measurement available.
Key exclusion criteria (1 listed)
- 1. Has any significant medical condition or other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-depth Interview (IDIs) or Focus Group Discussion (FGD) | Behavioural | Phase 1, Phase 2 HOPE participants, Phase 2 Male Partners |
Primary outcome
Factors affecting product use adherence
Time frame: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
Socio-contextual and trial specific issues which affected participants' adherence to the dapivirine VR will be captured by IDI and/or FGD.
Male partner attitudes affecting product use adherence
Time frame: Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
male partner attitudes towards and experiences with the dapivirine VR, and their perspective of their female partner's attitudes and experienceswill be captured by FGD and/or IDI.
4 secondary outcomes
Perceptions of HIV risk
Time frame: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
Product use patterns
Time frame: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
Perceptions of various adherence support interventions
Time frame: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
Understanding of ASPIRE results and ring efficacy
Time frame: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Results publication: PubMed 29957723Montgomery ET, Stadler J, Naidoo S, Katz AWK, Laborde N, Garcia M, Reddy K, Mansoor LE, Etima J, Zimba C, Chitukuta M, Soto-Torres L. Reasons for nonadherence to the dapivirine vaginal ring: narrative explanations of objective drug-level results. AIDS. 2018 Jul 17;32(11):1517-1525. doi: 10.1097/QAD.0000000000001868.
- Results publication: PubMed 33278181Naidoo K, Mansoor LE, Katz AWK, Garcia M, Kemigisha D, Morar NS, Zimba CC, Chitukuta M, Reddy K, Soto-Torres L, Naidoo S, Montgomery ET. Qualitative Perceptions of Dapivirine VR Adherence and Drug Level Feedback Following an Open-Label Extension Trial. J Acquir Immune Defic Syndr. 2021 Apr 1;86(4):e90-e96. doi: 10.1097/QAI.0000000000002590.
- Results publication: PubMed 33389318Montgomery ET, Katz AWK, Duby Z, Mansoor LE, Morar NS, Naidoo K, Tsidya M, Chitukuta M, Guma V, Tenza S, Leslie J, Garcia M, Naidoo S. Men's Sexual Experiences with the Dapivirine Vaginal Ring in Malawi, South Africa, Uganda and Zimbabwe. AIDS Behav. 2021 Jun;25(6):1890-1900. doi: 10.1007/s10461-020-03119-2. Epub 2021 Jan 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Montgomery, PhD, MHS study chair
RTI International
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Prevention, run by Microbicide Trials Network at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Africa, Zimbabwe, Malawi, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors affecting product use adherence (time frame: Phase 1: Four to six months during Q2/Q3 2016. Phase 2: Nine to twelve months during Q2 2018/Q2 2019.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02702895, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.