<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02999243</url>
  </required_header>
  <id_info>
    <org_study_id>1R34MH109359</org_study_id>
    <nct_id>NCT02999243</nct_id>
  </id_info>
  <brief_title>Development of an HIV Self-testing Intervention</brief_title>
  <official_title>Development of an HIV Self-testing Intervention to Reduce HIV Risks Among MSM: Taking the Guess Out of Seroguessing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jiangsu Provincial Center for Diseases Control and Prevention, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled trial (RCT) evaluates whether HIV self-testing (HIVST) facilitates&#xD;
      sexual harm reduction and reduces HIV transmission among HIV-negative MSM in China.The&#xD;
      intervention group will be offered HIVST kits plus harm reduction education, and followed 9&#xD;
      month, while the control group will receive harm reduction educational material only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The HIV epidemic in China is now concentrated among men who have sex with men (MSM), who&#xD;
      account for a third of new HIV infections. Despite strengthened prevention efforts and&#xD;
      increased availability of HIV testing in the country, testing rates are low and condomless&#xD;
      sex is common among Chinese MSM. Globally, condomless sex among MSM, particularly with&#xD;
      primary partners, is also ubiquitous. To reduce HIV transmission risks in the context of&#xD;
      condomless sex, MSM communities have adopted a range of sexual harm reduction strategies&#xD;
      (i.e., seroadaptive behaviors). Essential to the effectiveness of these strategies is&#xD;
      accurate knowledge of HIV status within the partnership. This necessitates frequent HIV&#xD;
      testing and mutual HIV status disclosure. However, significant proportions of MSM have never&#xD;
      tested or not recently tested and are unaware of their own and their partner's HIV status,&#xD;
      especially in settings where sexual minorities are stigmatized. Among Chinese MSM, their&#xD;
      ability to successfully use these harm reduction strategies is severely limited by low levels&#xD;
      of HIV testing and disclosure efficacy. As a result, many Chinese MSM make unreliable&#xD;
      assumptions about their own and their partners' serostatus (i.e., seroguessing), resulting in&#xD;
      risky condomless sex. As many of these men do not access facility-based testing, new and&#xD;
      emerging HIV testing options must be expanded to help these men make informed decisions about&#xD;
      sexual risk and harm reduction. HIV self-testing (HIVST) offers a promising prevention&#xD;
      strategy to reach more untested Chinese MSM, increase testing frequency, and serve as a&#xD;
      valuable prevention tool to assist harm reduction. The investigators propose to determine the&#xD;
      feasibility and preliminary efficacy of an HIVST intervention in facilitating sexual harm&#xD;
      reduction and reducing HIV transmission among MSM in Nanjing, China. The investigators will:&#xD;
      1) conduct participant observation (N = 20) and cognitive interviews (N=10) to determine what&#xD;
      information and support is needed for MSM to use HIVST safely and practice sexual harm&#xD;
      reduction responsibly; and 2) recruit and enroll 400 high-risk HIV-negative MSM into a RCT&#xD;
      where the intervention group will be offered HIVST kits plus harm reduction education and&#xD;
      followed over a 9-month period to determine whether the intervention increases uptake and&#xD;
      frequency of testing in partnership, improves disclosure and awareness of partners' HIV&#xD;
      status, and therefore facilitates sexual harm reduction and reduces HIV transmission.&#xD;
      Expanding HIV testing among key populations is a priority for HIV prevention worldwide.&#xD;
      Innovative strategies are needed to encourage MSM to seek HIV testing while taking into&#xD;
      consideration existing paradigms of community-originated and driven harm reduction&#xD;
      strategies. As HIVST is being introduced to different settings and becoming more accessible,&#xD;
      findings from this proposed study will provide vital information on current patterns of&#xD;
      seroadaptation and HIVST use; identify what is needed to promote HIVST's proper use for harm&#xD;
      reduction and linkage to HIV/STI care, and whether HIVST can improve the accuracy of harm&#xD;
      reduction strategies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    IRB expired, PI no longer at institution.&#xD;
  </why_stopped>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">May 21, 2018</completion_date>
  <primary_completion_date type="Actual">May 21, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in participants' HIV testing uptake</measure>
    <time_frame>Baseline and 9-month</time_frame>
    <description>Change in proportion of participants being tested for HIV</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in partners' HIV testing uptake</measure>
    <time_frame>Baseline and 9-month</time_frame>
    <description>Change in proportion of participants' partners who tested for HIV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire to assess change in awareness of partner's HIV status</measure>
    <time_frame>Baseline and 9-month</time_frame>
    <description>Change in proportion of participants' who report that they are aware of their partners' HIV status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire to assess change in self-reported sexually transmitted infection (STI) symptoms</measure>
    <time_frame>Baseline and 9-month</time_frame>
    <description>Change in proportion of participants who report symptoms of STIs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incident HIV infection</measure>
    <time_frame>Baseline and 9-month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>HIV Serosorting</condition>
  <arm_group>
    <arm_group_label>HIV self-testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HIV self-testing kits plus harm reduction education materials will be offered to the intervention group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Education</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Harm reduction educational materials will be offered to the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HIV self-testing</intervention_name>
    <description>The intervention group will be offered HIV self-testing kits for testing HIV status</description>
    <arm_group_label>HIV self-testing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Harm reduction education</intervention_name>
    <description>Both arms will receive harm reduction education</description>
    <arm_group_label>Education</arm_group_label>
    <arm_group_label>HIV self-testing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 years or older;&#xD;
&#xD;
          -  born male;&#xD;
&#xD;
          -  currently residing in Nanjing and planning to stay as a resident during the study&#xD;
             period;&#xD;
&#xD;
          -  speaks either Mandarin or the local dialect;&#xD;
&#xD;
          -  confirmed HIV negative through HIV rapid testing;&#xD;
&#xD;
          -  have had condomless anal sex with a man in the past six months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chongyi Wei, DrPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jiangsu Provincial Center for Disease Control and Prevention</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Li D, Li S, Liu Y, Gao Y, Yu M, Yang X, Li Q, Jiang S, Zhou Z, Zhang Z, Yan L, Jiang G, Xiao D, Pan SW, Luo F, Ruan Y, Shao Y. HIV incidence among men who have sex with men in Beijing: a prospective cohort study. BMJ Open. 2012 Nov 19;2(6):e001829. doi: 10.1136/bmjopen-2012-001829. Print 2012.</citation>
    <PMID>23166133</PMID>
  </reference>
  <reference>
    <citation>Wang QQ, Chen XS, Yin YP, Liang GJ, Zhang RL, Jiang N, Huan XP, Yang B, Liu Q, Zhou YJ, Wang BX. HIV prevalence, incidence and risk behaviours among men who have sex with men in Yangzhou and Guangzhou, China: a cohort study. J Int AIDS Soc. 2014 Aug 6;17(1):18849. doi: 10.7448/IAS.17.1.18849. eCollection 2014.</citation>
    <PMID>25103308</PMID>
  </reference>
  <reference>
    <citation>Xu JJ, Zhang M, Brown K, Reilly K, Wang H, Hu Q, Ding H, Chu Z, Bice T, Shang H. Syphilis and HIV seroconversion among a 12-month prospective cohort of men who have sex with men in Shenyang, China. Sex Transm Dis. 2010 Jul;37(7):432-9. doi: 10.1097/OLQ.0b013e3181d13eed.</citation>
    <PMID>20375928</PMID>
  </reference>
  <reference>
    <citation>Yan H, Yang H, Zhao J, Wei C, Li J, Huan X, Zhang M, Raymond HF, McFarland W. Long-chain peer referral of men who have sex with men: a novel approach to establish and maintain a cohort to measure HIV incidence, Nanjing, China. J Acquir Immune Defic Syndr. 2012 Feb 1;59(2):177-84. doi: 10.1097/QAI.0b013e318239c947.</citation>
    <PMID>21992923</PMID>
  </reference>
  <reference>
    <citation>Chow EP, Iu KI, Fu X, Wilson DP, Zhang L. HIV and sexually transmissible infections among money boys in China: a data synthesis and meta-analysis. PLoS One. 2012;7(11):e48025. doi: 10.1371/journal.pone.0048025. Epub 2012 Nov 29.</citation>
    <PMID>23209551</PMID>
  </reference>
  <reference>
    <citation>Snowden JM, Wei C, McFarland W, Raymond HF. Prevalence, correlates and trends in seroadaptive behaviours among men who have sex with men from serial cross-sectional surveillance in San Francisco, 2004-2011. Sex Transm Infect. 2014 Sep;90(6):498-504. doi: 10.1136/sextrans-2013-051368. Epub 2014 Mar 31.</citation>
    <PMID>24687128</PMID>
  </reference>
  <reference>
    <citation>Eaton LA, Kalichman SC, O'Connell DA, Karchner WD. A strategy for selecting sexual partners believed to pose little/no risks for HIV: serosorting and its implications for HIV transmission. AIDS Care. 2009 Oct;21(10):1279-88. doi: 10.1080/09540120902803208.</citation>
    <PMID>20024704</PMID>
  </reference>
  <reference>
    <citation>Xia Q, Molitor F, Osmond DH, Tholandi M, Pollack LM, Ruiz JD, Catania JA. Knowledge of sexual partner's HIV serostatus and serosorting practices in a California population-based sample of men who have sex with men. AIDS. 2006 Oct 24;20(16):2081-9. doi: 10.1097/01.aids.0000247566.57762.b2.</citation>
    <PMID>17053354</PMID>
  </reference>
  <reference>
    <citation>Mitchell JW, Horvath KJ. Factors associated with regular HIV testing among a sample of US MSM with HIV-negative main partners. J Acquir Immune Defic Syndr. 2013 Dec 1;64(4):417-23. doi: 10.1097/QAI.0b013e3182a6c8d9.</citation>
    <PMID>23933766</PMID>
  </reference>
  <reference>
    <citation>Centers for Disease Control and Prevention (CDC). Prevalence and awareness of HIV infection among men who have sex with men --- 21 cities, United States, 2008. MMWR Morb Mortal Wkly Rep. 2010 Sep 24;59(37):1201-7.</citation>
    <PMID>20864920</PMID>
  </reference>
  <reference>
    <citation>He N, Detels R. The HIV epidemic in China: history, response, and challenge. Cell Res. 2005 Nov-Dec;15(11-12):825-32. doi: 10.1038/sj.cr.7290354.</citation>
    <PMID>16354555</PMID>
  </reference>
  <reference>
    <citation>Gari S, Doig-Acuna C, Smail T, Malungo JR, Martin-Hilber A, Merten S. Access to HIV/AIDS care: a systematic review of socio-cultural determinants in low and high income countries. BMC Health Serv Res. 2013 May 28;13:198. doi: 10.1186/1472-6963-13-198.</citation>
    <PMID>23714167</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>January 21, 2020</last_update_submitted>
  <last_update_submitted_qc>January 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02999243
org study id: 1R34MH109359
nct id: NCT02999243
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This randomized controlled trial (RCT) evaluates whether HIV self-testing (HIVST) facilitates
      sexual harm reduction and reduces HIV transmission among HIV-negative MSM in China.The
      intervention group will be offered HIVST kits plus harm reduction education, and followed 9
      month, while the control group will receive harm reduction educational material only.
The HIV epidemic in China is now concentrated among men who have sex with men (MSM), who
      account for a third of new HIV infections. Despite strengthened prevention efforts and
      increased availability of HIV testing in the country, testing rates are low and condomless
      sex is common among Chinese MSM. Globally, condomless sex among MSM, particularly with
      primary partners, is also ubiquitous. To reduce HIV transmission risks in the context of
      condomless sex, MSM communities have adopted a range of sexual harm reduction strategies
      (i.e., seroadaptive behaviors). Essential to the effectiveness of these strategies is
      accurate knowledge of HIV status within the partnership. This necessitates frequent HIV
      testing and mutual HIV status disclosure. However, significant proportions of MSM have never
      tested or not recently tested and are unaware of their own and their partner's HIV status,
      especially in settings where sexual minorities are stigmatized. Among Chinese MSM, their
      ability to successfully use these harm reduction strategies is severely limited by low levels
      of HIV testing and disclosure efficacy. As a result, many Chinese MSM make unreliable
      assumptions about their own and their partners' serostatus (i.e., seroguessing), resulting in
      risky condomless sex. As many of these men do not access facility-based testing, new and
      emerging HIV testing options must be expanded to help these men make informed decisions about
      sexual risk and harm reduction. HIV self-testing (HIVST) offers a promising prevention
      strategy to reach more untested Chinese MSM, increase testing frequency, and serve as a
      valuable prevention tool to assist harm reduction. The investigators propose to determine the
      feasibility and preliminary efficacy of an HIVST intervention in facilitating sexual harm
      reduction and reducing HIV transmission among MSM in Nanjing, China. The investigators will:
      1) conduct participant observation (N = 20) and cognitive interviews (N=10) to determine what
      information and support is needed for MSM to use HIVST safely and practice sexual harm
      reduction responsibly; and 2) recruit and enroll 400 high-risk HIV-negative MSM into a RCT
      where the intervention group will be offered HIVST kits plus harm reduction education and
      followed over a 9-month period to determine whether the intervention increases uptake and
      frequency of testing in partnership, improves disclosure and awareness of partners' HIV
      status, and therefore facilitates sexual harm reduction and reduces HIV transmission.
      Expanding HIV testing among key populations is a priority for HIV prevention worldwide.
      Innovative strategies are needed to encourage MSM to seek HIV testing while taking into
      consideration existing paradigms of community-originated and driven harm reduction
      strategies. As HIVST is being introduced to different settings and becoming more accessible,
      findings from this proposed study will provide vital information on current patterns of
      seroadaptation and HIVST use; identify what is needed to promote HIVST's proper use for harm
      reduction and linkage to HIV/STI care, and whether HIVST can improve the accuracy of harm
      reduction strategies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Change in participants' HIV testing uptake
time frame: Baseline and 9-month
description: Change in proportion of participants being tested for HIV
measure: Change in partners' HIV testing uptake
time frame: Baseline and 9-month
description: Change in proportion of participants' partners who tested for HIV
measure: Questionnaire to assess change in awareness of partner's HIV status
time frame: Baseline and 9-month
description: Change in proportion of participants' who report that they are aware of their partners' HIV status
measure: Questionnaire to assess change in self-reported sexually transmitted infection (STI) symptoms
time frame: Baseline and 9-month
description: Change in proportion of participants who report symptoms of STIs
measure: Incident HIV infection
time frame: Baseline and 9-month
arm group label: HIV self-testing
arm group type: Experimental
description: HIV self-testing kits plus harm reduction education materials will be offered to the intervention group.
arm group label: Education
arm group type: Placebo Comparator
description: Harm reduction educational materials will be offered to the control group.
intervention type: Behavioral
intervention name: HIV self-testing
description: The intervention group will be offered HIV self-testing kits for testing HIV status
arm group label: HIV self-testing
intervention type: Behavioral
intervention name: Harm reduction education
description: Both arms will receive harm reduction education
arm group label: Education
arm group label: HIV self-testing
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Chongyi Wei, DrPH
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: China
citation: Li D, Li S, Liu Y, Gao Y, Yu M, Yang X, Li Q, Jiang S, Zhou Z, Zhang Z, Yan L, Jiang G, Xiao D, Pan SW, Luo F, Ruan Y, Shao Y. HIV incidence among men who have sex with men in Beijing: a prospective cohort study. BMJ Open. 2012 Nov 19;2(6):e001829. doi: 10.1136/bmjopen-2012-001829. Print 2012.
PMID: 23166133
citation: Wang QQ, Chen XS, Yin YP, Liang GJ, Zhang RL, Jiang N, Huan XP, Yang B, Liu Q, Zhou YJ, Wang BX. HIV prevalence, incidence and risk behaviours among men who have sex with men in Yangzhou and Guangzhou, China: a cohort study. J Int AIDS Soc. 2014 Aug 6;17(1):18849. doi: 10.7448/IAS.17.1.18849. eCollection 2014.
PMID: 25103308
citation: Xu JJ, Zhang M, Brown K, Reilly K, Wang H, Hu Q, Ding H, Chu Z, Bice T, Shang H. Syphilis and HIV seroconversion among a 12-month prospective cohort of men who have sex with men in Shenyang, China. Sex Transm Dis. 2010 Jul;37(7):432-9. doi: 10.1097/OLQ.0b013e3181d13eed.
PMID: 20375928
citation: Yan H, Yang H, Zhao J, Wei C, Li J, Huan X, Zhang M, Raymond HF, McFarland W. Long-chain peer referral of men who have sex with men: a novel approach to establish and maintain a cohort to measure HIV incidence, Nanjing, China. J Acquir Immune Defic Syndr. 2012 Feb 1;59(2):177-84. doi: 10.1097/QAI.0b013e318239c947.
PMID: 21992923
citation: Chow EP, Iu KI, Fu X, Wilson DP, Zhang L. HIV and sexually transmissible infections among money boys in China: a data synthesis and meta-analysis. PLoS One. 2012;7(11):e48025. doi: 10.1371/journal.pone.0048025. Epub 2012 Nov 29.
PMID: 23209551
citation: Snowden JM, Wei C, McFarland W, Raymond HF. Prevalence, correlates and trends in seroadaptive behaviours among men who have sex with men from serial cross-sectional surveillance in San Francisco, 2004-2011. Sex Transm Infect. 2014 Sep;90(6):498-504. doi: 10.1136/sextrans-2013-051368. Epub 2014 Mar 31.
PMID: 24687128
citation: Eaton LA, Kalichman SC, O'Connell DA, Karchner WD. A strategy for selecting sexual partners believed to pose little/no risks for HIV: serosorting and its implications for HIV transmission. AIDS Care. 2009 Oct;21(10):1279-88. doi: 10.1080/09540120902803208.
PMID: 20024704
citation: Xia Q, Molitor F, Osmond DH, Tholandi M, Pollack LM, Ruiz JD, Catania JA. Knowledge of sexual partner's HIV serostatus and serosorting practices in a California population-based sample of men who have sex with men. AIDS. 2006 Oct 24;20(16):2081-9. doi: 10.1097/01.aids.0000247566.57762.b2.
PMID: 17053354
citation: Mitchell JW, Horvath KJ. Factors associated with regular HIV testing among a sample of US MSM with HIV-negative main partners. J Acquir Immune Defic Syndr. 2013 Dec 1;64(4):417-23. doi: 10.1097/QAI.0b013e3182a6c8d9.
PMID: 23933766
citation: Centers for Disease Control and Prevention (CDC). Prevalence and awareness of HIV infection among men who have sex with men --- 21 cities, United States, 2008. MMWR Morb Mortal Wkly Rep. 2010 Sep 24;59(37):1201-7.
PMID: 20864920
citation: He N, Detels R. The HIV epidemic in China: history, response, and challenge. Cell Res. 2005 Nov-Dec;15(11-12):825-32. doi: 10.1038/sj.cr.7290354.
PMID: 16354555
citation: Gari S, Doig-Acuna C, Smail T, Malungo JR, Martin-Hilber A, Merten S. Access to HIV/AIDS care: a systematic review of socio-cultural determinants in low and high income countries. BMC Health Serv Res. 2013 May 28;13:198. doi: 10.1186/1472-6963-13-198.
PMID: 23714167
responsible party type: Sponsor
sharing ipd: No